1 - VCU Massey Cancer Center - Virginia Commonwealth University

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Title:
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Principal Investigator/Study
Chair/Coordinating Center:
Subinvestigator/Responsible Investigator:
Subinvestigator/Responsible Investigator:
Subinvestigator/Responsible Investigator:
Subinvestigator/Responsible Investigator:
Subinvestigator/Responsible Investigator:
Subinvestigator/Responsible Investigator:
Subinvestigator/Responsible Investigator:
Subinvestigator / Responsible Investigator:
Biostatistician:
Responsible Research Nurse:
Funding Sponsor:
Funding Sponsor:
Investigational Agent(s):
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PROTOCOL SUMMARY
Title:
Protocol Number:
IND Sponsor:
Principal Investigator
/Study Chair/
Coordinating Center:
Study Sites:
Clinical Trial Phase:
Study Disease:
Main Eligibility
Criteria:
Primary Objectives:
Secondary Objectives:
Endpoints:
Study Design:
Study Agent/
Intervention
Description:
Number of Subjects:
Subject Participation
Duration:
Estimated Time to
Complete Enrollment:
Statistical
Methodology:
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SCHEMA
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REVISION HISTORY
Revision history is presented in reverse order so that the information pertaining to the most
current version of the protocol is presented first in this section.
Version 1, Version Date MM/DD/YYYY
Initial submission of the protocol.
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TABLE OF CONTENTS
PROTOCOL SUMMARY ........................................................................................................... 2
SCHEMA ................................................................................................................................... 3
REVISION HISTORY ................................................................................................................. 4
TABLE OF CONTENTS ............................................................................................................ 5
LIST OF ABBREVIATIONS ....................................................................................................... 7
1
BACKGROUND .......................................................................................................... 8
1.1
1.2
1.3
1.4
2
STUDY DISEASE ............................................................................................................ 8
INVESTIGATIONAL AGENT(S) ........................................................................................... 8
OTHER AGENTS ............................................................................................................. 8
CORRELATIVE STUDIES BACKGROUND ............................................................................ 8
OBJECTIVES .............................................................................................................. 8
2.1
2.2
3
PRIMARY OBJECTIVES.................................................................................................... 8
SECONDARY OBJECTIVES .............................................................................................. 8
STUDY DESIGN.......................................................................................................... 8
3.1
3.2
3.3
4
GENERAL DESCRIPTION ................................................................................................. 8
PRIMARY ENDPOINT(S) .................................................................................................. 9
SECONDARY ENDPOINT(S) ............................................................................................. 9
PATIENT SELECTION ................................................................................................ 9
4.1
4.2
5
INCLUSION CRITERIA ...................................................................................................... 9
EXCLUSION CRITERIA .................................................................................................... 9
STUDY ENTRY AND WITHDRAWAL PROCEDURES ............................................... 9
5.1
5.2
6
STUDY ENTRY PROCEDURES.......................................................................................... 9
STUDY W ITHDRAWAL PROCEDURES ............................................................................... 9
TREATMENT PLAN ...................................................................................................10
6.1
6.2
6.3
6.4
6.5
6.6
6.7
6.8
BASELINE TESTS AND PROCEDURES ..............................................................................10
INVESTIGATIONAL AGENT ADMINISTRATION ....................................................................10
DEFINITION OF DLT AND MTD .......................................................................................10
ADDITIONAL TREATMENT MODALITIES ............................................................................11
GENERAL CONCOMITANT MEDICATION AND SUPPORTIVE CARE GUIDELINES ....................11
DURATION OF THERAPY ................................................................................................11
MONITORING SUBJECT COMPLIANCE .............................................................................11
FOLLOW -UP PERIOD .....................................................................................................11
7
DOSING DELAYS/DOSE MODIFICATIONS ..............................................................11
8
ADVERSE EVENTS: DEFINITIONS AND REPORTING REQUIREMENTS ..............12
8.1
8.2
8.3
8.4
8.5
DEFINITIONS .................................................................................................................12
KNOWN AES LIST .........................................................................................................13
TIME PERIOD AND GRADE OF AE CAPTURE ....................................................................13
PROCEDURES FOR RECORDING AES, SAES, AND UPS ...................................................14
ROUTINE REPORTING PROCEDURES FOR AES................................................................14
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8.6
9
EXPEDITED REPORTING PROCEDURES FOR SAES, UPS, AND DLTS ................................14
PHARMACEUTICAL INFORMATION ........................................................................15
9.1
10
10.1
10.2
11
11.1
11.2
11.3
AGENT #1 ....................................................................................................................15
MEASUREMENT OF EFFECT ...................................................................................16
ANTI-TUMOR EFFECT ....................................................................................................16
OTHER RESPONSE PARAMETERS ..................................................................................16
CORRELATIVE STUDIES/SPECIAL STUDIES .........................................................17
LABORATORY CORRELATIVE #1 .....................................................................................17
LABORATORY CORRELATIVE #2 .....................................................................................17
SHIPPING INSTRUCTIONS ..............................................................................................17
12
STUDY CALENDAR ..................................................................................................17
13
STATISTICAL CONSIDERATIONS ...........................................................................17
13.1
13.2
13.3
13.4
14
14.1
14.2
14.3
15
15.1
15.2
15.3
15.4
15.5
16
16.1
16.2
16.3
16.4
STUDY DESIGN AND ANALYSIS.......................................................................................17
SAMPLE SIZE/ACCRUAL RATES .....................................................................................17
STRATIFICATION FACTORS ............................................................................................17
ANALYSIS OF SECONDARY ENDPOINTS ..........................................................................17
DATA AND SAFETY MONITORING PLAN (DSMP) ..................................................17
STUDY TEAM ................................................................................................................18
AUDIT COMMITTEE ........................................................................................................18
DSMB .........................................................................................................................18
REGULATORY COMPLIANCE AND ETHICS ...........................................................18
ETHICAL STANDARD ......................................................................................................18
REGULATORY COMPLIANCE ...........................................................................................18
INSTITUTIONAL REVIEW BOARD .....................................................................................18
INFORMED CONSENT PROCESS .....................................................................................19
SUBJECT CONFIDENTIALITY AND ACCESS TO SOURCE DOCUMENTS/DATA........................19
DATA HANDLING AND RECORD KEEPING ............................................................20
DATA MANAGEMENT RESPONSIBILITIES .........................................................................20
SOURCE DOCUMENTS ...................................................................................................20
CASE REPORT FORMS (OR OTHER APPROPRIATE TITLE TO REFLECT THE STUDY-SPECIFIC
MANNER IN WHICH PROTOCOL-SPECIFIC DATA WILL BE RECORDED) ..................................20
STUDY RECORD RETENTION .........................................................................................20
17
REFERENCES ...........................................................................................................21
18
APPENDIX 1. INSERT TITLE HERE. .........................................................................22
19
INFORMED CONSENT TEMPLATE ..........................................................................23
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LIST OF ABBREVIATIONS
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1 BACKGROUND
1.1 Study Disease
1.2 Investigational Agent(s)
1.2.1 Preclinical Data
1.2.2 Clinical Data
1.2.3 Known and Potential Risks and Benefits
1.2.4 Rationale
1.3 Other Agents
1.4 Correlative Studies Background
2 OBJECTIVES
2.1 Primary Objectives
2.1.1
2.2 Secondary Objectives
2.2.1
3 STUDY DESIGN
3.1 General Description
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3.2 Primary Endpoint(s)
3.2.1
3.3 Secondary Endpoint(s)
3.3.1
4 PATIENT SELECTION
4.1 Inclusion Criteria
A potential subject must meet all of the following inclusion criteria to be eligible to
participate in the study.
4.1.1
4.1.2 Ability to understand and the willingness to sign a written informed consent
document.
4.2 Exclusion Criteria
A potential subject who meets any of the following exclusion criteria is ineligible to
participate in the study.
4.2.1
5 STUDY ENTRY AND WITHDRAWAL PROCEDURES
5.1 Study Entry Procedures
5.1.1 Required Pre-Registration Screening Tests and Procedures
Refer to section 11, STUDY CALENDAR, for the screening tests and procedures
that are required prior to registration, and for the timing of these events relative to
the start of treatment. (sample language)
5.1.2 Registration Process
5.2 Study Withdrawal Procedures
5.2.1 A patient may decide to withdraw from the study at any time.
5.2.2 A patient may be removed from treatment for one of the following criteria: (The 2
broad categories are as follows, although the first is frequently made more specific
as indicated below.)
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5.2.2.1 If in the opinion of the treating physician, it is in the best interest of the
patient to do so. (This is a generic statement that some investigators
prefer. You may want to include more specific criteria such as (i)
unwillingness or inability of the patient to comply with the protocol
requirements; (ii) disease progression; (iii) intercurrent illness that prevents
further administration of treatment; (iv) unacceptable adverse events
(AE[s]); and (v) general or specific changes in the patient's condition render
the patient unacceptable for further treatment in the judgment of the
investigator.)
5.2.2.2 Principal Investigator’s/Study Chair’s/Coordinating Center’s decision to
discontinue the study.
5.2.3 The reason for withdraw from the study and the date the patient was removed from
the study must be documented in the case report form (eCRF/CRF [choose one]).
6 TREATMENT PLAN
6.1 Baseline Tests and Procedures
6.2 Investigational Agent Administration
6.3 Definition of DLT and MTD
Management and dose modifications associated with the above AEs are outlined in section
7, DOSING DELAYS/DOSE MODIFICATIONS.
Dose escalation will proceed within each cohort according to the following scheme. DLT is
defined above.
Number of Patients with DLT
at a Given Dose Level
Escalation Decision Rule
0 out of 3
Enter 3 patients at the next dose level.
>2
Dose escalation will be stopped. This dose level will be
declared the maximally administered dose (highest dose
administered). Three (3) additional patients will be entered at
the next lowest dose level if only 3 patients were treated
previously at that dose.
1 out of 3
Enter at least 3 more patients at this dose level.
 If 0 of these 3 patients experience DLT, proceed to the next
dose level.
 If 1 or more of this group suffer DLT, then dose escalation
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is stopped, and this dose is declared the maximally
administered dose. Three (3) additional patients will be
entered at the next lowest dose level if only 3 patients were
treated previously at that dose.
<1 out of 6 at highest dose
level below the maximally
administered dose
This is generally the recommended phase 2 dose. At least 6
patients must be entered at the recommended phase 2 dose.
6.4 Additional Treatment Modalities
6.5 General Concomitant Medication and Supportive Care Guidelines
6.6 Duration of Therapy
6.7 Monitoring Subject Compliance
6.8 Follow-Up Period
Patients will be followed for # weeks/months/years after removal from the study treatment
or until death, whichever occurs first. Patients removed from the study treatment for
unacceptable AEs will be followed until resolution or stabilization of the adverse event.
7 DOSING DELAYS/DOSE MODIFICATIONS
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8 ADVERSE EVENTS: DEFINITIONS AND REPORTING
REQUIREMENTS
8.1 Definitions
8.1.1 Adverse Event (AE)
AE means any untoward medical occurrence associated with the use of a drug in
humans, whether or not considered drug related.
8.1.2 Serious AE (SAE)
An AE is considered “serious” if, in the view of the investigator, it results in any of
the following outcomes:

death,

a life-threatening AE (An AE is consider “life-threatening” if, in the view of the
investigator, its occurrence places the patient or subject at immediate risk of
death. It does not include an AE that, had it occurred in a more severe form,
might have caused death.),

inpatient hospitalization or prolongation of existing hospitalization,

a persistent or significant incapacity or substantial disruption of the ability to
conduct normal life functions, or

a congenital anomaly/birth defect.
Important medical events that may not result in death, be life-threatening, or require
hospitalization may be considered serious when, based upon appropriate medical
judgment, they may jeopardize the patient or subject and may require medical or
surgical intervention to prevent one of the outcomes listed in this definition.
8.1.3 Unanticipated Problem (UP)
Unanticipated problems include any incident, experience, or outcome that meets all
of the following criteria:

unexpected (in terms of nature, severity, frequency) given (a) the research
procedures that are described in the protocol-related documents, such as the
IRB-approved research protocol and informed consent document; and (b) the
characteristics of the subject population being studied;

related or possibly related to participation in the research (possibly related
means there is a reasonable possibility that the incident, experience, or outcome
may have been caused by the procedures involved in the research); and
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
suggests that the research places subjects or others at a greater risk of harm
(including physical, psychological, economic, or social harm) than was
previously known or recognized.
8.1.4 AE Description and Grade
The descriptions and grading scales found in the revised Common Terminology
Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
8.1.5 AE Expectedness
AEs can be ‘Unexpected’ or ‘Expected’.
Expected AEs are listed in section 8.2 below.
Unexpected AEs are those AEs occurring in one or more subjects participating in
the research protocol, the nature, severity, or frequency of which is not consistent
with either:

The known or foreseeable risk of AEs associated with the procedures involved
in the research that are described in (a) the protocol-related document, such as
the IRB-approved research protocol, any applicable investigator brochure, and
the current IRB-approved informed consent document, and other relevant
sources of information, such as product labeling and package inserts; or

The expected natural progression of any underlying disease, disorder, or
condition of the subject(s) experiencing the AE and the subject’s predisposing
risk factor profile for the AE.
8.1.6 AE Attribution

Definite – The AE is clearly related to the study treatment.

Probable – The AE is likely related to the study treatment.

Possible – The AE may be related to the study treatment.

Unlikely – The AE is doubtfully related to the study treatment.

Unrelated – The AE is clearly NOT related to the study treatment.
8.2 Known AEs List
8.3 Time Period and Grade of AE Capture
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8.4 Procedures for Recording AEs, SAEs, and UPs
8.5 Routine Reporting Procedures for AEs
8.6 Expedited Reporting Procedures for SAEs, UPs, and DLTs
The following table should be used for phase 1 trials with DLT reporting requirements:
Expedited Reporting Requirements (Events, Report Recipients, and Time Frames)
SAEs
UPs
DLTs
Principal
Investigator/Study Principal
Investigator/Study ___ CRA/CRN or other as
Chair/Coordinating Center1
Chair/Coordinating Center1)
specified3
4
1
Other
DSMB
Other4
IRB2
Other4
1
Report event within 5 business days of becoming aware of the occurrence.
2
VCU only study: Each UP must be reported to the VCU IRB within 5 business days of
becoming aware of the occurrence. The report must be prepared using the “VCU IRB PROMPT
REPORTING FORM,” found on the VCU IRB Forms Page.
or
For multi-institutional studies: VCU Investigators: Each UP, including those occurring at nonVCU sites, must be reported to the VCU IRB within 5 business days of becoming aware of the
occurrence. The report must be prepared using the “VCU IRB PROMPT REPORTING FORM,”
found on the VCU IRB Forms Page.
Non-VCU Investigators: Participating sites other than VCU should report AEs and UPs to their
respective IRBs according to their local institutional guidelines.
3
Report event within 1 business day of becoming aware of the occurrence. Receipt of reports is
confirmed. If confirmation is not received within one working day, the coordinating center should
be called by telephone (804- - ).
4
Used for any required reporting to other entities (such as a collaborating company, when that
entity/company is not an FDA-defined Sponsor). This section should be deleted if not needed.
Principal Investigator/Study
Chair/Coordinating Center
Massey Cancer Center DSMB
FAX: 804-828-5406
E-mail: [email protected]
CRA/CRN or other as specified
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The following table should be used for protocols that do not have DLT reporting
requirements.
Expedited Reporting Requirements (Events, Report Recipients, and Time Frames)
SAEs
UPs
Principal Investigator/Study
Chair/Coordinating Center1
Other3
Principal Investigator/Study Chair/Coordinating
Center1
DSMB1
IRB2
Other3
1
Report event within 5 business days of becoming aware of the occurrence.
2
VCU only study: Each UP must be reported to the VCU IRB within 5 business days of
becoming aware of the occurrence. The report must be prepared using the “VCU IRB PROMPT
REPORTING FORM,” found on the VCU IRB Forms Page.
or
For multi-institutional studies: VCU Investigators: Each UP, including those occurring at nonVCU sites, must be reported to the VCU IRB within 5 business days of becoming aware of the
occurrence. The report must be prepared using the “VCU IRB PROMPT REPORTING FORM,”
found on the VCU IRB Forms Page.
Non-VCU Investigators: Participating sites other than VCU should report AEs and UPs to their
respective IRBs according to their local institutional guidelines.
3
Used for any required reporting to other entities (such as a collaborating company, when that
entity/company is not an FDA-defined Sponsor). This section should be deleted if not needed..
Principal Investigator/Study
Chair/Coordinating Center
Massey Cancer Center DSMB
FAX: 804-828-5406
E-mail: [email protected]
Other
9 PHARMACEUTICAL INFORMATION
9.1 Agent #1
9.1.1 Product Description
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9.1.2 Solution Preparation
9.1.3 Storage Requirements
9.1.4 Stability
9.1.5 Route of Administration
9.1.6 Handling
9.1.7 Availability
9.1.8 Agent Ordering
9.1.9 Agent Accountability
9.1.10 Agent Destruction and Return
10 MEASUREMENT OF EFFECT
10.1 Anti-tumor Effect
10.2 Other Response Parameters
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11 CORRELATIVE STUDIES/SPECIAL STUDIES
11.1 Laboratory Correlative #1
11.2 Laboratory Correlative #2
11.3 Shipping Instructions
12 STUDY CALENDAR
13 STATISTICAL CONSIDERATIONS
13.1 Study Design and Analysis
13.2 Sample Size/Accrual Rates
13.3 Stratification Factors
13.4 Analysis of Secondary Endpoints
14 DATA AND SAFETY MONITORING PLAN (DSMP)
Include the following statement for a minimal risk study:
The DSMP for this study will consist of a single element, a study team:
Include the following statement for a study involving more than minimal risk.
The DSMP for this study will consist of the following 3 elements:
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14.1 Study Team
The study team minimally consists of the principal investigator, the research nurse, the
clinical research associate, and the study biostatistician. While subjects are on treatment,
the principal investigator, the research nurse, and the clinical research associate will meet
at least monthly, and will meet at least quarterly with the study biostatistician, to review
study status (attendees and time periods should be modified so as to make sense within
the context of the study). This review will include, but not be limited to, reportable AEs and
UPs, and an update of the ongoing study summary that describes study progress in terms
of the study schema. The appropriateness of further subject enrollment and the specific
intervention for a next subject enrollment are addressed. All meetings including attendance
are documented.
14.2 Audit Committee
This trial will be audited by the MCC Audit Committee.
14.3 DSMB
The study will be monitored by the MCC DSMB.
15 REGULATORY COMPLIANCE AND ETHICS
15.1 Ethical Standard
This study will be conducted in conformance with the principles set forth in The Belmont
Report: Ethical Principles and Guidelines for the Protection of Human Subjects of
Research (US National Commission for the Protection of Human Subjects of Biomedical
and Behavioral Research, April 18, 1979).
15.2 Regulatory Compliance
This study will be conducted in compliance with:

The protocol

Federal regulations, as applicable, including: 21 CFR 50 (Protection of Human
Subjects/Informed Consent); 21 CFR 56 (Institutional Review Boards); 21 CFR 312
(IND Application); and 45 CFR 46 Subparts A (Common Rule), B (Pregnant Women,
Human Fetuses and Neonates), C (Prisoners), and D (Children)
15.3 Institutional Review Board
Each participating institution must provide for the review and approval of this protocol and
the associated informed consent documents and recruitment material by an appropriate
IRB registered with the Office for Human Research Protections (OHRP). Any amendments
to the protocol or consent materials must also be approved. In the United States and in
other countries, only institutions holding a current US Federalwide Assurance issued by
OHRP may participate.
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15.4 Informed Consent Process
Informed consent is a process that is initiated prior to the individual’s agreeing to
participate in the study and continues throughout the individual’s study participation.
Extensive discussion of risks and possible benefits of this therapy will be provided to the
subjects and their families. Consent forms describing in detail the study interventions/
products, study procedures, and risks are given to the subject and written documentation
of informed consent is required prior to starting intervention/administering study product.
Consent forms will be IRB-approved and the subject will be asked to read and review the
document. Upon reviewing the document, the investigator will explain the research study to
the subject and answer any questions that may arise. The subject will sign the informed
consent document prior to any procedures being done specifically for the study. The
subjects should have the opportunity to discuss the study with their surrogates or think
about it prior to agreeing to participate. The subjects may withdraw consent at any time
throughout the course of the trial. A copy of the informed consent document will be given to
the subjects for their records. The rights and welfare of the subjects will be protected by
emphasizing to them that the quality of their medical care will not be adversely affected if
they decline to participate in this study.
15.5 Subject Confidentiality and Access to Source Documents/Data
Subject confidentiality is strictly held in trust by the participating investigators and their
staff, [and the sponsor(s) and their agents] (include bracketed portion if applicable). This
confidentiality includes the clinical information relating to participating subjects, as well as
any genetic or biological testing.
The study protocol, documentation, data, and all other information generated will be held in
strict confidence. No information concerning the study or the data will be released to any
unauthorized third party without prior written approval of the principal investigator/study
chair (choose one as appropriate).
If not covered in a separate agreement, the sponsor should ensure the
investigators/institutions will allow access to all source data and documents for the
purposes of monitoring, audits, IRB review, and regulatory inspections. Sample text below:
The principal investigator/study chair (choose one as appropriate) will allow access to all
source data and documents for the purposes of monitoring, audits, IRB review, and
regulatory inspections. Source documents provided to coordinating center for the purpose
of auditing or monitoring will be de-identified and labeled with the study number, subject
ID, and patient initials (include this sentence if protocol is conducted at more than one
site).
The study monitor or other authorized representatives of the principal investigator/study
chair (choose one as appropriate) may inspect all documents and records required to be
maintained by the investigator, including but not limited to, medical records (office, clinic, or
hospital) and pharmacy records for the subjects in this study. The clinical study site will
permit access to such records.
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16 DATA HANDLING AND RECORD KEEPING
16.1 Data Management Responsibilities
The principal investigator is responsible for: (i) the overall conduct of the investigation; (ii)
ongoing review of trial data including all safety reports; and (iii) apprising participating sites
of any UPs.
The responsible investigator at each site is responsible for: (i) the data management at his
or her site; and (ii) reporting SAEs, UPs, and DLTs as required in section 8.
Any laboratory conducting correlative studies must maintain the laboratory records and
documentation (laboratory notebooks, laboratory protocols, print-outs, recordings,
photographs, etc.).
16.2 Source Documents
Source documents for clinical information (patient history, diagnosis, clinical and diagnostic
test reports, etc.) are maintained in the patient’s clinical file. Source documents for the
correlative studies are maintained in laboratory conducting the study.
16.3 Case Report Forms (or other appropriate title to reflect the study-specific manner in
which protocol-specific data will be recorded)
Sample text below for eCRFs:
MCC Oncore data management will provide standard electronic case report forms (eCRFs)
and create study-specific eCRFs to capture all the information required by the protocol.
The eCRFs will be approved by the study team to ensure the most effective data
acquisition. All information on eCRFs will be traceable to the source documents which are
generally maintained in the subject’s file. All eCRFs should be completed and available for
collection within a timely manner, preferably no more than 14 days after the subject’s visit.
If the study does not involve eCRFs, a description of the manner in which the data will be
recorded and maintained should be provided. If handwritten documents will be maintained,
the following text can serve as a model for data entry.
All entries on the case report forms (CRFs) should be made legibly in black ink. Errors,
when made, should be corrected by drawing a single line through the incorrect entry (do
not erase, white-out, or tape over errors) and then entering the correct data above the
original entry. Entry corrections should be initialed and dated. Explain missing data with
“ND” for “not determined” and “NA” used for “not applicable.”
16.4 Study Record Retention
As applicable, study records will be maintained a minimum of 5 years beyond: (i) the
publication of any abstract or manuscript reporting the results of the protocol; (2) the
submission of any sponsored research final report; or (iii) submission of a final report to
clinicaltrials.gov.
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17 REFERENCES
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18 APPENDIX 1. INSERT TITLE HERE.
Add material.
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19 INFORMED CONSENT TEMPLATE
The VCU IRB Biomedical Template (rev 5-15-12) is incorporated below. You should check the
IRB Web site prior to customizing the template to ensure that it is the most current version
available. If a newer template is available it should be used rather than the version below.
Instructions for completion are imbedded in the document.
Language in blue below is suggested or required language from CTEP Informed Consent
Template (August 2011)
TITLE:
VCU IRB PROTOCOL NUMBER:
INVESTIGATOR:
SPONSOR: [if no sponsor for this research, delete this field]
This template is based on a drug or device research study. The same elements/sections are
required for other research studies (psychology, sociology, etc.). See Social-Behavioral
Consent Template on VCU IRB Web site.
Instructions and comments are in italics and [ ]. Block and delete most after reading and
following if needed. Find “drug name” and replace the initial use of the term with the actual
generic name of the drug if it exists and any brand, chemical, or slang name you will be using
later in the consent. Subsequent replacement of “drug name” may be with the generic, brand,
chemical, or slang name of the drug, in a consistent manner. Find “disease name” and replace
with the actual disease or condition. Delete those sections that are not applicable.
If any information contained in this consent form is not clear, please ask the study doctor or the
study staff to explain any information that you do not fully understand. You may take home an
unsigned copy of this consent form to think about or discuss with family or friends before making
your decision.
[Include if appropriate] In this consent form, “you” always refers to the research participant. If
you are a legally authorized representative, please remember that “you” refers to the study
participant.
PURPOSE OF THE STUDY
[What follows are only examples. If they are not applicable, remove the language and explain
the purpose of the study.]
[Option 1] The purpose of this research study is to test the safety, tolerability, and effectiveness
of the drug name when used to treat disease name. You are being asked to participate in this
study because you have been diagnosed with disease name, and may meet the study entry
requirements.
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[Option 2] Disease causes symptoms or condition, which may involve [insert short discussion of
how or why the drug might affect the disease or condition. Cannot promise efficacy or safety.
Alter the wording if the study has a different purpose, for example, is limited only to safety and
tolerability, no efficacy.].
DESCRIPTION OF THE STUDY
[What follows is an example. If not applicable, remove this language and provide a description
of the study.]
Drug name is an investigational drug, which means it has not been approved by the U.S. Food
and Drug Administration (FDA). In this study, drug name will be compared to , an approved
drug, and to placebo (a look-alike inactive substance). [or other, depending on design]
Your participation in this study will last up to [insert length of time]. Approximately [insert how
many] individuals will participate in this study.
Significant new findings developed during the course of the research [Insert new findings such
as additional risks or discomforts] which may relate to your willingness to continue participation
will be provided to you.
PROCEDURES
[If any of the treatments or procedures have not been well studied, include a statement that the
treatment or procedure might involve risks to the participant, which are currently unforeseeable.]
[What follows is an example. Your narrative must include any invasive and/or non-standard
procedures, and any procedures that are experimental.]
If you decide to be in this research study, you will be asked to sign this consent form after you
have had all your questions answered.
At your first study visit (Visit 1), your medical history will be taken and a physical exam will be
performed. This exam will include measurements of your weight and vital signs (pulse, blood
pressure and temperature). Blood and urine samples will be collected for routine lab tests.
Approximately 1 to 2 tablespoons of blood will be collected. [If done, mention pregnancy test at
this time.]
Ex: Women of childbearing potential will have a pregnancy test done.
[If tests are done that require reporting of positive results to the Health Department (e.g.,
hepatitis, HIV, STDs), these must be mentioned, along with that information.]
Ex: Your blood sample will also be tested for hepatitis and HIV. Virginia state law requires the
study staff to report the results of positive tests for hepatitis and HIV to a local health agency.
You will have an electrocardiogram (ECG - tracing of the electrical activity of the heart).
[If random]
You will be randomly assigned (like the flip of a coin) to receive either [insert] or [Insert]. [Can
also list as bullets, if several arms]
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You have [insert] chance in [insert] of being assigned to placebo, and [insert] chance in [insert]
of receiving [insert].
[Or can say] You have an equal chance of being assigned to any one of the groups.
[If double-blind]
Neither you nor the study doctor will know which study drug (or procedure or treatment, etc.)
you are receiving. This information is available to the study doctor if needed in an emergency.
This is done (blinding) so that a fair evaluation of results may be made.
[If single blind] [Be sure the procedure discussion does not “blow the blind”]
You will not know which study drug you are receiving. This is done (blinding) so that a fair
evaluation of results may be made.
[If visits are frequent, complicated, or involve varying activities, consider inserting a
table in this section, or providing a pull out table as an appendix]
Visit 2 will take place [insert] after Visit 1. Your vital signs will be measured, and [insert]. If you
qualify for the study, you will be given study drug and you will be instructed on how to take your
study drug.
Visits 3 through 6 will be scheduled at [insert]. At each visit except Visit 6, your vital signs will be
checked, and [insert]. You will be asked about your health since the last visit. You will receive a
new supply of study drug and [insert].
Visit 6, the last visit, will include a physical exam, ECG and blood and urine samples for lab
tests. You will be asked about your overall experience with the study drug.
At each visit, you should bring all of your remaining study drug supply to the research clinic.
[List tests and procedures and their frequency under the categories below. Include whether a
patient will be at home, in the hospital, or in an outpatient setting.]
Before you begin the study …
You will need to have the following exams, tests or procedures to find out if you can be
in the study. These exams, tests or procedures are part of regular cancer care and may
be done even if you do not join the study. If you have had some of them recently, they
may not need to be repeated. This will be up to your study doctor.

[List tests and procedures as appropriate. Use bulleted format.]
During the study …
If the exams, tests and procedures show that you can be in the study, and you choose to
take part, then you will need the following tests and procedures. They are part of regular
cancer care.

[List tests and procedures as appropriate. Use bulleted format.]
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You will need these tests and procedures that are part of regular cancer care. They are
being done more often because you are in this study.

[List tests and procedures as appropriate. Use bulleted format. Omit this section if no
tests or procedures are being done more often than usual.]
You will need these tests and procedures that are either being tested in this study or
being done to see how the study is affecting your body.

[List tests and procedures as appropriate. Use bulleted format. Omit this section if no
tests or procedures are being tested in this study or required for safety monitoring.]
[For randomized studies:] You will be "randomized" into one of the study groups described
below. Randomization means that you are put into a group by chance. A computer
program will place you in one of the study groups. Neither you nor your doctor can
choose the group you will be in. You will have an [equal/1 in 3/etc.] chance of being placed
in any group.
If you are in group 1 (often called "Arm A") … [Explain what will happen for this group with
clear indication of which interventions depart from routine care.]
If you are in group 2 (often called "Arm B")… [Explain what will happen for this group with
clear indication of which interventions depart from routine care.]
[For studies with more than 2 groups, an explanatory paragraph containing the same type of
information should be included for each group.]
When I am finished taking [drugs or intervention]…[Explain the follow-up tests, procedures,
exams, etc. required, including the timing of each and whether they are part of standard cancer
care or part of standard care but being performed more often than usual or being tested in this
study. Define the length of follow-up.]
[Optional Feature: In addition to the mandatory narrative explanation found in the preceding
text, a simplified calendar (study chart) or schema (study plan) may be inserted here. The
schema from the protocol should not be used as it is too complex, however a simplified version
of the schema is encouraged. Instructions for reading the calendar or schema should be
included. See examples.]
Study Chart [Example]
You will receive [drug(s) or intervention] every [insert appropriate number of days or weeks] in
this study. This [insert appropriate number of days or weeks] period of time is called a cycle.
The cycle will be repeated [insert appropriate number] times. Each cycle is numbered in
order. The chart below shows what will happen to you during cycle 1 and future
treatment cycles as explained previously. The left-hand column shows the day in the
cycle and the right-hand column tells you what to do on that day.
Cycle 1
Day
Two days
What you do
 Get routine blood tests.
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before
starting
study
Day before
starting
study

Check-in to _____________ the evening before starting study.

Begin taking ______ once a day. Keep taking _____ until the end of study, unless told
to stop by your health care team.
Day 2

Leave _______________ and go to where you are staying.
Day 8
Day 15
Day 22






Get routine blood tests.
Get routine blood tests.
Get routine blood tests.
Get routine blood tests and exams.
Get 2nd chest x-ray for research purposes.
Return to your doctor’s office at _______ [insert appointment time] for your next exam
and to begin the next cycle.
Day 1
Day 28
Day 29
Future cycles
Day
Days 1-28
What you do
 Keep taking _____ once a day if you have no bad side effects and cancer is not
getting worse. Call the doctor at _____________ [insert phone number] if you do not
know what to do.
 Get routine blood tests each week (more if your doctor tells you to).
 Get routine blood tests and exams every cycle (more if your doctor tells you to).
 Get routine X-rays, CT scans, or MRIs every other cycle (more if your doctor tells you
to).
Study Plan [Example]
Another way to find out what will happen to you during the study is to read the chart
below. Start reading at the top and read down the list, following the lines and arrows.
Start Here
Continue with study details
RISKS AND DISCOMFORTS
[What follows is only an example.]
[If there are more than 3-4 side effects in a list, please present in a vertical, bulleted format for
ease of reading. Also please use the non-technical meaning, rather than a medical term (ex,
use “gas” instead of “flatulence”, or “weakness” instead of “asthenia”)] Ex:
Possible side effects associated with the use of drug name include:
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
headache

dizziness

sleepiness

nausea

indigestion
Allergic reaction to drug name is possible. Severe allergic reactions can be life-threatening.
[Or side effect information supplied by the sponsor]
[If any of the treatments or procedures have not been well studied in pregnant women, include a
statement that the treatment or procedure might involve risks to the participant (if applicable,
insert: or to the embryo or fetus, if the participant is or may become pregnant) that are currently
unforeseeable.]
[Include risks and side effects for each comparator drug, if any].
[IF APPLICABLE]
[For women only studies]
As the study procedures might injure an unborn child, pregnant women may not participate.
Women who might become pregnant should use a medically accepted form of birth control such
as total abstinence, birth control pills, an IUD, diaphragm, progesterone injections or implants,
or condoms plus a spermicide. Methods of birth control other than total abstinence are not
100% effective, and should a women become pregnant there is a risk of injury to an unborn
child. For similar reasons, women who are nursing an infant may not participate.
[For studies with women and men]
As the study procedures might injure an unborn child, pregnant women may not participate.
Women who might become pregnant should use a medically accepted form of birth control such
as total abstinence, birth control pills, an IUD, diaphragm, progesterone injections or implants,
or condoms plus a spermicide. Methods of birth control other than total abstinence are not
100% effective, and should a women become pregnant there is a risk of injury to an unborn
child. For similar reasons, women who are nursing an infant may not participate.
For men, the study procedures might increase the risks for birth defects of any child conceived
during treatment and several months after treatment is stopped. Men in this study who have the
potential of fathering children should be aware of this possibility and consider using a medically
accepted form of birth control.
[For men only studies]
For men, the study procedures might increase the risks for birth defects of any child conceived
during treatment and several months after treatment is stopped. Men in this study who have the
potential of fathering children should be aware of this possibility and consider using a medically
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accepted form of birth control. For men this would include total abstinence and condoms plus a
spermicide, or for the female partner, birth control pills, an IUD, diaphragm, progesterone
injections or implants. Methods of birth control other than total abstinence are not 100%
effective, and should a women become pregnant there is a risk of injury to an unborn child.
[List risks of other procedures if needed especially any invasive procedure (ex, if study required
tympanocentesis, or endoscopy, or endometrial biopsy, etc.). Also include imaging and x-ray
studies if in excess of what would be done as part of standard treatment.]
[If a treatment study, include]
Your condition may not get better or may become worse while you are in this study.
[If study drug is taken home, include]
Only the study participant can take the study drug. It must be kept out of the reach of children
and persons who may not be able to read or understand the label.
While participating in this clinical trial, your study doctor advises that you stop taking all herbal
products, certain dietary supplements, and any complementary or alternative medications, as
these may have unexpected or bad effects on your health in combination with the experimental
drugs being used in this trial. Tell all your study team and health care providers about any
medications you take, including prescription drugs, over-the-counter medicines, herbal products,
vitamins, dietary supplements, or complementary or alternative therapies. Give your providers a
full picture of what you do to manage your health. This will help ensure coordinated and safe
care. For tips about talking with your health care providers about complementary or alternative
health care practices, see NCCAM’s Time to Talk campaign at
http://nccam.nih.gov/timetotalk/forpatients.htm.
BENEFITS TO YOU AND OTHERS
[What follows are examples. If not applicable, remove this language and describe any benefits
to the participants and others, which may reasonably be expected from the research.]
There is no guarantee that you will receive any medical benefits from being in this study.
[If not a treatment study] This is not a treatment study, and you are not expected to receive any
direct medical benefits from your participation in the study. The information from this research
study may lead to a better treatment in the future for people with disease name. You may
benefit from the physical exams, ECGs, lab tests, and other study procedures.
[Include if appropriate] Please be aware that the investigative team and the university may
receive money for the conduct of this study.
COSTS
Study drug will be provided by the sponsor. There are no charges for the study visits. [Or other
list as appropriate] [If will be billed for any additional costs, need to tell them, also that insurance
may not pay for research charge.]
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You and/or your health plan/ insurance company will need to pay for some or all of the costs of
treating your cancer in this study. Some health plans will not pay these costs for people taking
part in studies. Check with your health plan or insurance company to find out what they will pay
for. Taking part in this study may or may not cost your insurance company more than the cost of
getting regular cancer treatment.
(If applicable, inform the patient of any tests or procedures for which there is no charge. Indicate
if the patient and/or health plan is likely to be billed for any charges associated with these ‘free’
tests or procedures.)
(Include the following section if a study agent is manufactured by a drug company and
provided.)
The (identify study agent supplier here using the most appropriate choice of the following
options: NCI, Cooperative Group, or another NCI-supported Clinical Trials Network) will supply
the [study agent(s)] at no charge while you take part in this study. The (insert name of study
agent supplier identified in first sentence) does not cover the cost of getting the [study
agent(s)] ready and giving it to you, so you or your insurance company may have to pay
for this.
Even though it probably won’t happen, it is possible that the manufacturer may not
continue to provide the [study agent(s)] to the (insert name of study agent supplier identified
in first sentence) for some reason. If this would occur, other possible options are:

You might be able to get the [study agent(s)] from the manufacturer or your pharmacy
but you or your insurance company may have to pay for it.

If there is no [study agent(s)] available at all, no one will be able to get more and the
study would close.
If a problem with getting [study agent(s)] occurs, your study doctor will talk to you about
these options. (End of section)
(Include the following section if a study agent is manufactured by the NCI and provided at no
charge)
The NCI will provide the [study agent(s)] at no charge while you take part in this study. The
NCI does not cover the cost of getting the [study agent(s)] ready and giving it to you, so
you or your insurance company may have to pay for this.
Even though it probably won’t happen, it is possible that the NCI may not be able to
continue to provide the [study agent(s)] for some reason. If this would happen, the study
may have to close. Your study doctor will talk with you about this, if it happens. (End of
section)
PAYMENT FOR PARTICIPATION
[Only need to have if are paying, or the protocol says must inform are not paying. Use
straightforward language and always include the per visit amount.]
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Ex: You will be paid $_____ if you complete all scheduled study visits. If you withdraw from the
study before completion, you will be paid $_____ per completed study visit. Total payments
within one calendar year that exceed $600 will require the university to annually report these
payments to the IRS and you. This may require you to claim the compensation you receive for
participation in this study as taxable income. VCU is required by federal law to collect your
social security number. Your social security number will be kept confidential and will only be
used to process payment.
ALTERNATIVE TREATMENT
If you decide not to enter this study, there are other treatments available. These include [List of
major drugs and/or therapies]. The study doctor will discuss these with you. You do not have to
participate in this study to be treated for disease name.
[If not a treatment study - Remove “Treatment” from section title and add] Your alternative is not
to participate in this study.
CONFIDENTIALITY
Potentially identifiable information about you will consist of [List e.g., tissue samples, surveys,
interview notes and recordings, audiotapes of consultations and interviews, and data abstracted
from the medical record]. Data is being collected only for research purposes. [Note how the data
will be identified, stored and protected]. Ex: Your data will be identified by ID numbers and
birthdates, not names, and stored separately from medical records in a locked research area.
All personal identifying information will be kept in password protected files and these files will be
deleted note time frame]. Other records [Note which ones] will be kept in a locked file cabinet for
[Note time frame] after the study ends and will be destroyed at that time. [Note which files] will
be kept indefinitely. Access to all data will be limited to study personnel. A data and safety
monitoring plan is established.
You should know that research data or (medical information if applicable) about you may be
reviewed or copied by the sponsor of the research or by Virginia Commonwealth University.
Personal information about you might be shared with or copied by authorized officials of the
Federal Federal Drug Administration, or the Department of Health and Human Services (if
applicable).
[Include this language (required by the FDA) if this study is a clinical trial] A description of this
clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This
Website will not include information that can identify you. At most, the Web site will include a
summary of the results. You can search this Web site at anytime.
[If research is conducted in foreign countries include the following statement:] If the research is
conducted in foreign countries (where a study drug or device may be considered for approval),
personal information pertaining to you may be shared or copied by authorized agents of
governmental agencies in those countries.
Although results of this research may be presented at meetings or in publications, identifiable
personal information pertaining to participants will not be disclosed.
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DATA REGISTRIES
[Consider implementing the following layered levels of consent if a registry is being created or
you will be contributing to an existing registry. Layers may not be required, although participants
may feel they have more control over their participation. If utilizing these layers, your registry
must have provisions for respecting them.]
1. I give permission for my data/tissue samples to be stored and used for research related to
[insert topic]
YES ____________________
NO ____________________
2. I give permission for my data/tissue samples to be stored and used for future research about
other health problems.
YES ____________________
NO ____________________
3. I give permission for my data/tissue samples to be stored; however, I want to be contacted
prior to any future use of my data/tissue samples for research.
YES ____________________
NO ____________________
GENETIC TESTING
[Only need to have if genetic testing is involved.]
[For Multicenter protocols (not initiated at VCU)]
[Include a description of the research plan with attention to the special concerns raised by
genetic testing. (These concerns may be inferred from the section on VCU-initiated protocols
below.) Investigators may need to modify the proposed informed consent form in order to
provide this information. If participants may make choices concerning the use of their samples,
these should be indicated in a check-off format (see below). Investigators should take care,
however, that the modified informed consent form reflects that the actual research plan. This
may be difficult if the research plan is vague.]
[For VCU-initiated protocols, the following issues should be addressed]
Background information: The research involves genetic testing. Genetic testing may reveal
information about the likelihood that a person or his or her relatives may develop certain
diseases. Genetic testing may reveal information about who is related to whom. If known to
employers or insurance companies, the results of genetic testing might affect a person's ability
to obtain a job or health or life insurance.
Current and future studies: [Consider implementing the following layered levels of consent:]
[If giving the patient this option, there must be a process in place to ensure that the choice can
be complied with.]
1.
My blood/tissue samples may be stored and used for future research about [insert topic].
YES
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initial
2.
initial
My blood/tissue samples may be stored and used for future research about other health
problems (for example, heart disease, osteoporosis, diabetes, etc.)
YES
NO
initial
initial
Future contact concerning further genetic testing research: [Describe the circumstances
under which participants might be contacted in the future concerning further participation in this
or related genetic testing research. Consider offering the participant the option of opting out of
such contacts at this time with a Yes/No response to a question formatted like those above.]
Future contact concerning genetic testing results: [If planned or possible future genetic
testing results are unlikely to have clinical implications, then a statement that the results will not
be made available to participants may be appropriate. If results might be of clinical significance,
then describe the circumstances and procedures by which participants would receive results.
Describe how participants might access genetic counseling for assistance in understanding the
implications of genetic testing results, and whether this might involve costs to participants.
Investigators should be aware that federal regulations, in general, require that testing results
used in clinical management must have been obtained in a CLIA-certified laboratory.]
Withdrawal of genetic testing consent: [Describe whether and how participants might in the
future request to have test results and/or samples withdrawn in order to prevent further analysis,
reporting, and/or testing.]
Confidentiality: [Describe the extent to which genetic testing results will remain confidential
and special precautions, if any, to protect confidentiality.]
COMPENSATION FOR INJURY or ILLNESS [This element is required for greater than minimal
risk research as per §46.116(a)(6) and 21CFR50. It is not required, and generally not
appropriate, for expedited research; no waiver of this element needs to be requested]
If you are injured by, or become ill, from participating in this study, please contact your study
doctor immediately. Medical treatment is available at the Virginia Commonwealth University
Health System (VCU Health System). Your study doctor will arrange for short-term emergency
care at the VCU Health System or for a referral if it is needed.
Fees for such treatment may be billed to you or to appropriate third party insurance. Your health
insurance company may or may not pay for treatment of injuries or illness as a result of your
participation in this study.
To help avoid research-related injury or illness it is very important to follow all study directions.
VOLUNTARY PARTICIPATION AND WITHDRAWAL
Your participation in this study is voluntary. You may decide to not participate in this study. Your
decision not to take part will involve no penalty or loss of benefits to which you are otherwise
entitled. If you do participate, you may freely withdraw from the study at any time. Your decision
to with draw will involve no penalty or loss of benefits to which you are otherwise entitled.
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Your participation in this study may be stopped at any time by the study doctor or the sponsor
without your consent. The reasons might include:

the study doctor thinks it necessary for your health or safety;

you have not followed study instructions;

the sponsor has stopped the study; or

administrative reasons require your withdrawal.
If you leave the study before the final regularly scheduled visit, [Insert any consequences of a
participant’s decision to withdraw from the research (i.e., side effects of tapering off of study
drug(s),condition may worsen)) and procedures for orderly termination of participation by the
subject (i.e., tapering off of study drug(s), follow-up visits with study team or patient’s
physician).]
QUESTIONS
If you have any questions, complaints, or concerns about your participation in this research,
contact:
[Insert name and contact information of contact person for study]
and/or
[Insert name and contact information of additional contact person for study – (optional)]
[List the name of the contact person and his/her contact information here. The contact person
should be a full-time faculty or staff person. More than one contact may be listed. Give name
and role of primary contact first. Use bold type and larger font for names and contact
information.]
The researcher/study staff named above is the best person(s) to call for questions about
your participation in this study.
If you have general questions about your rights as a participant in this or any other research,
you may contact:
Office of Research
Virginia Commonwealth University
800 East Leigh Street, Suite 113
P.O. Box 980568
Richmond, VA 23298
Telephone: (804) 827-2157
Contact this number for general questions, concerns, or complaints about research. You may
also call this number if you cannot reach the research team or if you wish to talk to someone
else. General information about participation in research studies can also be found at
http://www.research.vcu.edu/irb/volunteers.htm
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Do not sign this consent form unless you have had a chance to ask questions and have
received satisfactory answers to all of your questions..
CONSENT
[Change consent to permission if parents or legal guardian are agreeing to child’s participation.
Add “My child” language as needed]
I have been provided with an opportunity to read this consent form carefully. All of the questions
that I wish to raise concerning this study have been answered.
By signing this consent form, I have not waived any of the legal rights or benefits, to which I
otherwise would be entitled. My signature indicates that I freely consent to participate in this
research study. I will receive a copy of the consent form once I have agreed to participate.
________________________________________________
Participant Name, printed
________________________________________________
Participant Signature
________________
Date
[NOTE: DELETE THE PARENT OR LEGAL GUARDIAN LINES UNLESS THE STUDY
ALLOWS FOR THE ENROLLMENT OF CHILDREN] 1
_______________________________________________
Name of Parent or Legal Guardian
(Printed)
_______________________________________________
Parent or Legal Guardian Signature
________________
Date
[NOTE: DELETE THE LEGALLY AUTHORIZED REPRESENTATIV LINES UNLESS THE
STUDY ALLOWS FOR THE INVOLVEMENT OF ADULTS WHO ARE UNABLE TO PROVIDE
CONSENT] 2
_______________________________________________
Name of Legally Authorized Representative
(Printed)
_______________________________________________
Legally Authorized Representative Signature
________________
Date
________________________________________________
Name of Person Conducting Informed Consent
Discussion / Witness 3
(Printed)
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________________________________________________
Signature of Person Conducting Informed Consent
Discussion / Witness
________________
Date
________________________________________________
Principal Investigator Signature (if different from above)
________________
Date 4
1
[If the study allows for the involvement of children, the permission of BOTH parents is required
for certain categories of research unless one is deceased, unknown, incompetent, or only one
parent has legal responsibility for care and custody. The categories of research are: (a)
research involving greater than minimal risk and no prospect of direct benefit to individual
subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition
(45.CFR 46.406) or (b) research not otherwise approvable which presents an opportunity to
understand, prevent, or alleviate a serious problem affecting the health and welfare of children.
(45.CFR 46.407) Include lines for BOTH parents to print their names and lines for BOTH
signatures and date if the research involves one of the two categories listed above.]
2
[If the study allows for the involvement of adults who are unable to provide consent, the
consent of a legally authorized representative is required.]
3
[A witness to the signature of a research participant is required by VA Code. If the witness is to
be someone other than the person conducting the informed consent discussion, include a line
for the witness to print his/her name and lines for signature and date.]
4
[The purpose of this signature is to ensure that the principal investigator is aware of who has
been enrolled in studies. The principal investigator’s signature date need not correspond to that
of subject or witness, but should be provided after both the subject and witness have signed.]
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