AMERICAN COLLEGE OF RADIOLOGY IMAGING NETWORK
ACRIN 66##
INSERT TITLE TO THE PROTOCOL
ACRIN PROSPECTIVE TRIAL TEMPLATE
[Include phase (phase I, phase II, etc.), design of the trial, if the trial is multi-center, the
investigational agent, and the and target disease]
Study Chair
Insert the Name of the Study Chair
Insert Department Name/Affiliation
Insert University/Affiliation
Insert Address
Insert Phone Number
Insert Fax Number
Insert e-mail address
Other co-investigators as needed
Statistician
Insert the Name of the Study Chair
Insert Department Name/Affiliation
Insert University/Affiliation
Insert Address
Insert Phone Number
Insert Fax Number
Insert e-mail address
Original Date:
Version Date:
Activation Date:
Insert date of final and approved protocol
Insert date of first amendment of the protocol (Any additional amendments
will be inserted as necessary)
On activated protocols only
CONFIDENTIAL
This protocol was designed and developed by the American College of Radiology Imaging
Network (ACRIN). It is intended to be used only in conjunction with institution-specific
IRB approval for study entry. No other use or reproduction is authorized by ACRIN, nor
does ACRIN assume any responsibility for unauthorized use of this protocol.
CONFIDENTIAL
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Table of Contents
Schema
1.0
Abstract ..................................................................................................................................
2.0
Background and Significance ................................................................................................
3.0
Specific Aims/Objectives.......................................................................................................
4.0
Study Overview .....................................................................................................................
5.0
Participant Selection ..............................................................................................................
6.0
Site Selection .........................................................................................................................
7.0
Online Registration [and Randomization] System ................................................................
8.0
Study Procedures ...................................................................................................................
9.0
Data Collection and Management ..........................................................................................
10.0
Data Collection Forms ...........................................................................................................
11.0
Image Submission ..................................................................................................................
12.0
Adverse Events Reporting .....................................................................................................
13.0
Ethical Considerations ...........................................................................................................
14.0
Conflict of Interest .................................................................................................................
15.0
Publication Policy ..................................................................................................................
16.0
Institutional Audits.................................................................................................................
17.0
Statistical Considerations ......................................................................................................
References ..........................................................................................................................................
Appendix I:
Sample Informed Consent Form ................................................................................
Appendix II: Registration/Eligibility Checklist...............................................................................
Appendix III: Participating Institutions ............................................................................................
Add other appendices as needed
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AMERICAN COLLEGE OF RADIOLOGY IMAGING NETWORK
ACRIN XXXX: Insert Full TITLE of protocol
SCHEMA
INCLUDE A SIMPLE SCHEMA ILLUSTRATING THE PROCEDURES AND TIMELINES.
This section of the protocol should contain the following information:
SPECIFIC AIMS/OBJECTIVES
Study Objectives (brief statement of primary endpoints)
METHODS/METHODOLOGY
Stratification criteria (if applicable)
Arm(s) descriptions (if applicable)
Procedure or treatment description
Diagram of procedure or treatment sequence (if applicable)
ELIGIBILITY (see Section 5.0 for details)
[Eligibility should appear as bulleted items]
Note the main clinical disease and the key inclusion criteria (the entire list of the inclusion criteria will
appear later in the protocol).
REQUIRED SAMPLE SIZE
Total number of subjects projected for the entire study (all sites combined for multi-center protocol)
STUDY DESIGN
Very brief description of the main elements of the study design and the primary endpoint to be used in
the trial.
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1.0
ABSTRACT
This protocol for human research study is conducted according to US and international standards of
Good Clinical Practice (International Conference on Harmonization (ICH) Guidelines), applicable
government regulations (e.g. Title 45, Part 46 Code of Federal Regulations) and the American College
of Radiology Imaging Network (ACRIN) research policies and procedures.
[Stated aims should coincide with Section 3.0.]
This section should contain information about the target disease. It should include descriptions of and
information about the investigational agent or modality. Also include the rationale for the protocol/trial
development with information about non-clinical and clinical data available to date. It is also
appropriate to discuss why the risks are reasonable in relation to the anticipated benefits and/or
knowledge that might reasonably be expected from the study.
2.0
BACKGROUND AND SIGNIFICANCE
This section should contain the following information:
 History of the procedure/treatment
 References to pertinent studies, and the rationale for the proposed modalities
 Public health impact – start with prevalence of disease(s) and expected morbidity/mortality
This section should summarize all available non-clinical and clinical data (published or available
unpublished data) that could have clinical significance and have relevance to the protocol under
development.
3.0
SPECIFIC AIMS/OBJECTIVES
This section describes the overall objectives, including primary and any secondary objectives/endpoints
(if applicable):
 Questions to be answered by the results of the study
 Study end points, which correlate with endpoints in statistical section
4.0
STUDY OVERVIEW
Describe the approximate total number or range of participants to be recruited for study within the
approximate recruitment timeframe. Provide an estimation or number of how many sites are anticipated
to participate in the trial and the expected number of participants to be recruited by each site.
Should be brief description of procedures/treatment and follow-up and refer to appropriate Sections and
Appendices for details.
5.0
PARTICIPANT SELECTION
5.1
Inclusion Criteria
Create a numbered list (i.e. 5.1.1, 5.1.2, etc.) of criteria participants must meet to be eligible for
study enrollment (e.g. age, gender, targeted disease) at the time of the registration visit. It
should include “must be able to provide a written informed consent.”
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5.2
Exclusion Criteria
Create a numbered list (i.e. 5.2.1, 5.2.2, etc.) of criteria that would exclude a participant from
study enrollment at the time of the registration visit. If appropriate, should generally include
that the subjects cannot have an active drug/alcohol dependence or abuse history. Also consider
whether women or men must use clinically approved birth control while participating on this
study, or whether women must have a negative pregnancy test.
5.3
Recruitment and Screening
Describe how potential participants will be identified and recruited for the study (e.g.
investigator, co-investigators and/or site investigators, clinical practices, physician referrals,
institutional database, advertisements [handouts, brochures, posters, letters to referring
physicians etc.]). It must be noted that all advertisements and any information being
disseminated to potential study participants MUST be reviewed and approved by the institution’s
local IRB.
Describe any screening requirements necessary to meet any noted inclusion or exclusion criteria
(detailed information can be included in the “Study Procedure” section of the protocol).
5.4
Inclusion of Women and Minorities
(Depending on the study, this section on inclusion of women may or may not be necessary)
Both men and women and members of all ethnic groups are eligible for this trial. In
conformance with the National Institutes of Health (NIH) Revitalization Act of 1993
with regard to inclusion of women and minority in clinical research the projected
gender and minority accruals are shown below:
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Gender and Minority Accrual Estimates
Sex/Gender
Ethnic Category
Females
Males
Unknown
Total
Hispanic or Latino
Not Hispanic or Latino
Unknown
Ethnic Category: Total of all subjects
Racial Category
American Indian or Alaskan Native
Asian
Black or African American
Native Hawaiian or other Pacific Islander
White
More than one race
Unknown
Racial Category: Total of all subjects
Describe how the proposed study will target and recruit the population of men and women and
members of diverse ethnic communities. Note: This chart is required only for Phase II and
Phase III studies.
6.0
SITE SELECTION
6.1
Institution Requirements
Describe any study-specific investigator/site qualifications and equipment requirements. If these
are detailed, they may be summarized here and listed more fully in an appendix or in Protocol
Specific Application.
6.2
7.0
IRB Approval and Informed Consent
All institutions must have study-specific Institutional Review Board (IRB) approval for
the protocol and informed consent form. (The informed consent form is included in
this protocol as Appendix <<#>>.) The investigator and the investigator-designated
research staff must follow OHRP-approved consent procedures (Title 45, Part 46 Code
of Federal Regulations), as well as those set by the local IRB at the institution. A copy
of the IRB approval letter and a copy of the IRB approved, institutional study-specific
consent form must be on file at ACRIN Headquarters (fax: 215-574-0300, ATTN:
Protocol Development and Regulatory Compliance Department) prior to registering the
first participant.
ONLINE REGISTRATION AND RANDOMIZATION (optional: study specific) SYSTEM
7.1
Using the Online Registration System
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Once the investigator-designated research staff (i.e. the Research Associate [RA]) has
completed the eligibility checklist (Appendix <<#>>) and the participant has been
found to be eligible, the participant may be consented. Upon obtaining a signed
informed consent form, the information of the study participant will be registered by
logging onto the ACRIN web site (www.acrin.org), which is available 24 hours a day,
7 days a week. Please refer to the ACRIN Procedure Manual, Section 7.1,
Participant Registration for instructions.
8.0
7.2
Unsuccessful Registrations
7.2.1
ACRIN and protocol-specific requirements for Institution participation are maintained
within the Administrative database. The protocol specific attributes are then interfaced
with the web application for on-line verification of site participation acceptance. If the
institution has not met all the regulatory requirements based on the required attributions
within the database, a screen that includes a brief explanation of the failure to gain
access to the registration screens is projected. If during the completion of the eligibility
questions a participant is deemed ineligible based on a response, a message box appears
to instruct the research staff to contact the Data Management Center.
7.2.2
In the unlikely event that the ACR web registration site is not accessible, participating
sites may still register a participant by faxing the completed eligibility checklist to the
DMC at the ACR (215-717-0936, ATTN: PARTICIPANT REGISTRATION). ACR
staff will fax a response to the registering site with the confirmation of registration and
participant case number and randomization (study specific -- optional) as soon as
possible.
STUDY PROCEDURES
Describe all the study procedures and diagnostic treatments required at each visit. A study table
that describes the activities and procedures to be conducted at each visit is useful and helpful.
Include this study table as an appendix that can be referred to in this section.
8.1
Registration Visit
List all study procedures and activities to be performed at the registration visit.
8.2
Visit 1
Indicate the timeframe for this visit (e.g. Visit 1 will occur six (6) months from the
registration/baseline visit with +/- one (1) week [a window/timeframe]). List all
“follow-up” study procedures and activities to be performed at this visit.
8.3
Visit 2…etc.
Indicate the timeframe for this visit (e.g. Visit 2 will occur after six (6) months from
Visit 1 with +/- one (1) week [a window/ timeframe]). List all “follow-up” study
procedures and activities to be performed at this visit.
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8.4
Study Parameters
Study Procedure
PreRegistratio
n Visit
VISIT 1:
VISIT 2:
VISIT 3:
VISIT 4:
Signed Informed Consent
ACRIN Web Registration
Medical History
Medical Record
<<Insert Study Procedures>>
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Etc.
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9.0
DATA COLLECTION AND MANAGEMENT
9.1
General
9.1.1
The ACRIN web address is www.acrin.org.
9.1.2
Data collection and management will be performed by the Biostatistics and Data
Management Center (BDMC) of ACRIN under the direction of Dr. Constantine
Gatsonis. The Biostatistics Center (BC) is located at Center for Statistical Sciences at
Brown University in Providence, RI, and the Data Management Center (DMC) is
located at the American College of Radiology’s Data Management Department in
Philadelphia.
9.1.3
Participant enrollment and data collection occurs through a series of programmed
screens accessed through the ACRIN web site to register/randomize participants,
collect participant data, and maintain calendars of data submissions for each
participant. By using the World Wide Web, ACRIN has made participant registration,
data entry, and updated calendar information available to clinical sites 24 hours a day,
seven days a week. Each successful case registration is confirmed through receipt of an
e-mail containing a registration/randomization confirmation and a case specific
calendar identifying timelines for data and image submission. If the confirmation email is not received, the enrolling person should contact the Data Management Center
before attempting a re-registration.
9.2
Clinical Data Submission
Upon successful participant registration, a confirmation e-mail containing the registration and case
specific calendar is sent to the research staff enrolling the participant via the web. In addition, the
investigator-designated research staff may download the participant specific data submission calendar,
which lists all forms and designated reports required by protocol, along with the form due dates at the
DMC. These calendars will be updated as the study proceeds to reflect data that have been received,
reply deadlines for queries about unclear data, deadlines for follow-up reports of adverse events, or
changes in the protocol that change the data being collected or the timeframe. Updated calendars for
each participant can be obtained 24 hours a day from the ACRIN website. The research associate may
use the calendar as a case management tool for data submission and follow-up scheduling.
9.2.2
The investigative site is required to submit data according to protocol as detailed on
each participant’s calendar, as long as the case status is designated as open/alive or
until the study is terminated. The case is closed when all data have been received,
reviewed and no outstanding data query exists for the case.
9.2.3
To submit data via the ACRIN website, the appropriate investigator-designated
research staff will log onto the ACRIN web site and supply the pre-assigned user name
and password. Case report forms will be available on the web site through a series of
links. Each web form is separated into modules; each module must be completed
sequentially in order for the internal programming to be accurate. The user selects the
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link to the appropriate form and enters data directly into the web-based form. As
information is entered into the web form application, various logic checks will be
performed. These logic checks look for missing data, data that are out of range, and
data that are in the wrong format (e.g. character data in a field requiring numeric
responses). Such errors will be detected as soon as the user attempts to either submit
the form or move to the next data element. They must be corrected before the form is
transmitted to the DMC. The user will not be able to finalize form transmission to the
DMC until all data entered pass these logic checks. Forms that are not completed in
one sitting can still be submitted and completed at a later date. The form will remain
available on the web until the “Complete Form Submission” button is depressed.
9.2.4
Once data entry of a form is complete, and the summary form reviewed for
completeness and accuracy, the investigator or the research staff presses the “Complete
Form Submission” button on the form summary screen and the data is transferred into
the clinical database. No further direct revision of the submitted data is allowed after
this point. E-mail confirmation of web data entry is automatically generated and sent to
the site investigator or research associate listing all of the data completed and just
submitted. Should a problem occur during transmission and the e-mail confirmation of
data submission is not received, the investigator or research associate should contact
the Data Management Center for resolution of the submission.
If a temporary problem prevents access to the Internet, all sites are notified of the event and estimated
down time through an ACRIN broadcast message. The investigative site should wait until access is
restored to submit data. The site RA or investigator should notify the DMC of the problem and the
DMC will give an estimated time when access will be restored. If access will be unavailable for an
extended period, sites must seek another Internet Service Provider (ISP). On a short-term basis, the
ACR can serve as an ISP.
9.3
Data Security
The registration and data collection system has a built-in security feature that encrypts
all data for transmission in both directions, preventing unauthorized access to
confidential participant information. Access to the system will be controlled by a
sequence of identification codes and passwords.
9.4
Electronic Data Management
9.4.1
Data received from the web-based forms are electronically stamped with the date and
time of receipt by the ACRIN server. The data are then entered into the database. A
protocol-specific validation program is used to perform more extensive data checks for
accuracy and completeness. Complimentary validation programs are initiated at the
Brown Biostatistics Center and the Data Management Center. The logic checks
performed on the data at this point are more comprehensive than those built into the
web-based data entry screens. They include checking that answers are logical, based
on data entered earlier in the current form and the more thorough checks. Data
elements that fail validation are followed up by the DMC research associate. The
validation program generated by BC produces a log of errors, which is sent to the DMC
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Research Associate (RA) for resolution. The program is frequently updated to
incorporate exceptions to rules so that subsequent validity checks minimize the time the
DMC RA at the DMC needs to spend resolving problems. Additional data review will
take place once the data is transferred to the BC. The BC will run thorough cross-form
validations, frequency distributions to look for unexpected patterns in data, and other
summaries needed for study monitoring. Any errors found at the BC will be reported to
the DMC RA for resolution. All BDMC communication with the participating sites is
normally done through the Data Management Center.
9.4.2
If checks at DMC or BC detect missing or problematic data, the DMC RA sends a
Request for Information (Z1 query letter) to the site RA or investigator specifying the
problem and requesting clarification. The DMC RA updates the participant’s data
submission calendar with the due date for the site RA or investigator’s response.
9.5
Missing and Delinquent Data Submission
In addition to providing the investigator a data collection calendar for each case, the
DMC periodically prompts institutions for timely submission of data through the use of
a Forms Due Report. Distributed at intervals via the electronic mail system directly to
both the RA and the investigator at each site, this report lists data items (e.g. forms,
reports, and images) that are delinquent and those that will be due before the next report
date. In addition to prompting clinicians to submit overdue data, the Forms Due Report
helps to reconcile the DMC’s case file with that of the RA and/or investigator. Future
Due Forms Report may be sent on an as needed basis in addition to past due reports.
The site investigator or research associate may use the Forms Due and Future Due
Reports as a case management tool.
9.6
Data Quality Assurance
9.6.1
The Biostatistical Center (BC) at Brown University will maintain a study database at
its site for monitoring data quality and for performing analyses. These data are drawn
directly from the permanent database of the Data Management Center (DMC). The
transfer of data between the DMC and the BC has been validated through a series of
checks consisting of roundtrip data verification in which data are sent back and forth to
verify that the sent data are equivalent to the received data. These checks are repeated
at random intervals during the course of a given study. Any discrepancies and other
data quality issues will be referred to DMC for resolution, since only the DMC can
correct the data file. No changes to the data will be made at the BC.
9.6.2
A goal of the monitoring of data is to assess compliance with the protocol and to look
for unforeseen trends that may be indicative of procedural differences among clinical
sites. If patterns are discovered in the data that appear to arise from causes specific to
an institution, the Biostatistical and Data Management Center (BDMC) will apprise the
ACRIN Headquarters and the site of the problem, and work with the site, along with
ACRIN Protocol Development and Regulatory Compliance Department, until the
problem has been resolved. If the BDMC, along with the Audit Group, cannot find a
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resolution to the problem, it will be brought to the Steering Committee for further
discussion and resolution.
10.0
DATA COLLECTION FORMS
Forms development can occur in parallel with waiting for CTEP approval. However, data
elements to be collected should be identified (to be developed) early in the protocol development
phase.
(Includes data collection table and submission timeline)
Form
Submission Timeline
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11.0
IMAGE SUBMISSION
Provide the specific modality requirements and a description of the actual films/images to be
collected for this trial. Provide any additional information regarding equipment, especially if
computer equipment will be supplied to the participating institutions.
Digitally generated and scanned film images can be transmitted to the ACRIN Imaging
Management Center (IMC) via FTP directly to the image archive.
All images are requested to be in digital format, unless indicated otherwise. ACRIN has
developed software that allows for electronic transmission of images to the IMC that have been
scrubbed of all participant identifiers. ACRIN will contact each site individually to determine
their readiness and ability to utilize this system. For preliminary questions, contact <<Imaging
Department contact person, i.e. Anthony Levering>> at <<contact person phone number and/or
email address, i.e. alevering@phila.acr.org>> or <<Imaging Management Center Contact
Person, i.e. Rex Welsh at <<IMC contact person phone number and/or email address, i.e. (215)
574-3215>>. Once technical capabilities have been established, imaging personnel from
ACRIN will coordinate the image transmission process and options and train all operating
research staff.
11.1
When [description of type of images, i.e. mammogram film] images are not available
digitally and/or direct transfer to electronic media (CD, magneto-optical disk [MOD],
ZIP disk, tape), original films must be submitted via mail for digitization at the IMC
and subsequent entry to the image archive. For film submissions, all unique patient
identifiers must be removed from the film, and the only identifiers on the film should
be as follows: Institution ID, ACRIN Case Number, and ACRIN Study Number. A
film/screen data log should be included in the shipment of these films. All electronic
media and film will be maintained at ACRIN Headquarters, unless otherwise requested.
Return packaging and postage will be provided.
Film images or images on CD should be addressed and sent to:
ACRIN Image Archive
ACRIN Protocol <<Protocol Number XXXX>> Images
American College of Radiology
1818 Market Street, Suite 1600
Philadelphia, PA 19103
Attn: <<Insert Image Archive Contact>>
11.2
If required and part of the protocol, images maintained at ACRIN Headquarters Image
Archive may be distributed to other participating sites, using either FTP, MOD, or CDROM where appropriate, for purposes of secondary review.
The header recorded on DICOM formatted image data often contains information identifying the
participant by name. These identifiers must be scrubbed before the images are transferred.
This involves replacing the following:
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 Participant Name tag with the ACRIN Institution ID or number
 Participant ID tag with the ACRIN case number, and
 Other Participant ID tag with ACRIN Study Number.
This process can be completed by utilizing the software program available at the
institution, or the software program provided by ACRIN.
11.2.2 In the event that the site does not have DICOM capability or is unable to
transfer images with scrubbed headers, the images may be sent on a CD or other
electronic medium to ACRIN IMC for digitization/transfer to the Image
Archive. Please contact the ACRIN IMC prior to sending the media to confirm
compatibility.
11.2.3 Images stored in the ACRIN IMC Image Archive will be forwarded to other
participating sites, using FTP, MOD or CDROM where appropriate, for
purposes of secondary interpretation.
12.0
ADVERSE EVENTS REPORTING
Expedited reporting may not be appropriate for certain protocols where an adverse event is
expected. The exception or acceptable reporting procedures must be specified in the text of the
approved protocol. Therefore, the protocol specific adverse event guidelines would supersede
the standard guidelines for adverse event reporting.
12.1
Definition of Adverse Event
An Adverse Event (AE) is any untoward medical occurrence in a participant that does
not necessarily have a causal relationship with the study intervention. An AE can
therefore be any unfavorable and unintended sign (including an abnormal laboratory or
physiological finding), symptom, or disease temporally associated with the use of a
medical treatment or procedure, regardless of whether it is considered related to the
medical treatment or procedure (attribution of unrelated, unlikely, possible, probable, or
definite). Abnormal results of diagnostic procedures are considered to be adverse
events (AEs) if the abnormality:





12.2
results in study withdrawal
is associated with a serious adverse event
is associated with clinical signs or symptoms
leads to additional treatment or to further diagnostic tests
is considered by the investigator to be of clinical significance
Definition of Serious Adverse Event
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that:




results in death, or
is life-threatening (at the time of the event),or
requires inpatient hospitalization or prolongation of an existing hospitalization, or
results in persistent or significant disability or incapacity, or
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 is a congenital anomaly/birth defect.
All adverse events that do not meet the criteria of serious should be regarded as nonserious adverse events.
12.3
Adverse Event Grading
Grade is used to denote the severity of the adverse event. An AE is graded using the
current version of the Common Terminology Criteria for Adverse Events (CTCAE), or
the following categories (if the term does NOT appear in the current version of the
CTCAE):
1 – Mild
2 – Moderate
3 – Severe
4 – Life-threatening or disabling
5 – Fatal
(For terms listed in the CTCAE, the grade is still recorded as 1, 2, 3, 4, or 5; however,
the definition of the various grades will be specific to the term being used.)
12.4
Adverse Event Attribution
Attribution is used to determine whether an adverse event is related to a study treatment
or procedure. An adverse event may be considered associated with the study
treatment/procedure if there is reasonable possibility that the adverse event may be
caused by the <<study treatment/procedure>>. An adverse event may be considered
NOT associated with the study treatment/procedure if there is not a reasonable
possibility that the adverse event may have been caused by the <<study
treatment/procedure>>. Attribution categories are:
Definite – AE is clearly related to the study treatment or procedure.
Probable – AE is likely related to the study treatment or procedure.
Possible – AE may be related to the study treatment or procedure.
Unlikely – AE is doubtfully related to the study treatment or procedure.
Unrelated–AE is clearly NOT related to the study treatment or procedure.
12.5
Expected Adverse Events from [intervention/modality]____________
List in separate sections any expected adverse events from each intervention/modality.
12.6
Reporting of Adverse Events
Prompt reporting of adverse events is the responsibility of each investigator, clinical
research associate, and/or nurse engaged in clinical research. Please refer to the
ACRIN Adverse Event Reporting Manual for specific details about what to report and
when. Anyone uncertain about whether a particular adverse event should be reported
should contact the ACRIN headquarters at 215-574-3150 for assistance. Any event
that is judged NOT to be related to the treatment or procedure should NOT be
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reported as an adverse event. However, an adverse event report should be submitted
if there is a reasonable suspicion of the medical treatment or imaging procedure.
All unresolved adverse events should be followed by the investigator until the events
are resolved, the subject is lost to follow-up, or the adverse events are otherwise
explained. Any death or adverse event (e.g. development of cancer, congenital
anomaly in conceived offspring) occurring at any time after a subject has discontinued
or terminated study participation that may be reasonably be related to the medical
treatment or imaging effect should be reported.
Any adverse events that result in hospitalization or prolonged hospitalization should be
documented and reported as serious AEs unless specifically stated otherwise in the
protocol. Any condition responsible for surgery should be documented as an AE if the
condition meets the criteria for an adverse event.
The condition, hospitalization, prolonged hospitalization, or surgery should NOT be
reported as an AE in the following situations:
 For diagnostic or elective surgical procedures for a pre-existing condition. Surgery
should not be reported as an outcome of an adverse event if the surgery was elective
or diagnostic and it was uneventful.
 If it is required to allow efficacy measurement for the study.
 For therapy for the target disease of the study, unless it is a worsening or increase in
frequency of hospital admissions as judged by the clinical investigator.
A pre-existing medical condition is defined as an adverse event if this medical
condition worsens after the subject has been entered into the study.
12.7
When to Report
12.7.1
You must use expedited adverse event reporting within 10 working days of knowledge
of the event for all unexpected and expected Grade 4 and Grade 5 events occurring
within 30 days of the study intervention, regardless of attribution. An expedited report
is required for unexpected Grade 2 and Grade 3 adverse events with an attribution of
possible, probable or definite and must be reported within 10 working days. These
reports should be sent to ACRIN, NCI’s Cancer Imaging Program (CIP), and the local
Institutional Review Board (IRB). Copies of each report and documentation of the
notification and receipt will be kept in the study file.
12.7.2
All fatal (Grade 5) adverse events should also be reported by telephone to NCI and
ACRIN within 24 hours of knowledge of the event.
12.7.3
Expedited adverse event reporting is NOT required for expected events of grades 1-4 or
unexpected-indirect adverse events of any grade.
12.8
How to Report
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12.8.1
An expedited adverse event report requires submission to the NCI/CIP and ACRIN
using the paper templates “Adverse Event Expedited Report—Single Agent” or
“Adverse Event Expedited Report—Multiple Agents,” available on the CTEP home
page, http://ctep.info.nih.gov. Protocols involving only imaging procedures must be
submitted using a paper version. Investigators following those protocols should omit
the Course Information section and the Protocol Agent section, even though the
template indicates those as mandatory. (Do not try to send the form via the web site; it
will not accept a form without those fields filled in.)
12.8.2
Completed expedited reports should be sent to:
<<Insert the Name >>, NCI/CIP Program Director
Re: Adverse Event Report
Cancer Imaging Program
6130 Executive Blvd., MSC 7412
Bethesda, MD 20892-7412
To make a telephone report, contact NCI at (301) 496-0737, available 24 hours a day
(recorder after hours from 4:30 PM to 8:00 AM Eastern Time).
13.0
12.8.3
A copy of all expedited adverse event reports should be sent to ACRIN by fax at (215)717-0936. All fatal adverse events should be reported by telephone within 24-hours of
the event. To make a telephone report to ACRIN, call (215)-717-2763, available 24
hours a day (recorder after hours from 4:30 PM to 8:00 AM Eastern Time).
12.8.4
All expedited adverse event reports should be sent to your local Institutional Review
Board (IRB). Adverse events not requiring expedited reporting are normally reported
to the local IRB in an annual report.
ETHICAL CONSIDERATIONS
This study is to be conducted according to US and international standards of Good Clinical
Practice [International conference of Harmonization (ICH) guidelines], applicable government
regulations, and ACRIN research policies and procedures.
This protocol and any amendments will be submitted to a properly constituted independent
Ethics Committee (EC) or Institutional Review Board (IRB) for a formal approval of the study
conduct. The decision of the EC/IRB concerning the conduct of the study will be made in
writing to the investigator and a copy of this decision will be provided to ACRIN before
implementation of the study. The investigator will provide ACRIN with the institution’s
assurance number, along with the IRB approval letter.
All study participants in this study will be provided a consent form describing the study and
providing sufficient information for participants to make informed decisions about their
participation in this study (see Appendix <<#>> for a copy of the sample informed consent
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form). This consent form will be submitted along with the protocol for review and approval by
the EC/IRB. The study participant MUST be consented with the EC/IRB approved consent form
before the participant is subjected to any study procedures. The approved consent form MUST
be signed and dated by the study participant or legally acceptable representative and the
investigator-designated research staff obtaining the consent.
14.0
CONFLICT OF INTEREST
Any investigator and/or research staff member who has a conflict of interest with this study
(such as patent ownership, royalties, or financial gain greater than the minimum allowable by
their institution) must fully disclose the nature of the conflict of interest in accordance with
ACRIN policies and applicable federal, state, and local laws and regulations.
15.0
PUBLICATION POLICY
Delete or modify the following sample language:
Neither complete nor any part of the results of the study obtained under this protocol, nor any
information provided to the investigator for the purposes of performing the study, will be
published or passed on to any third party without the consent of ACRIN <<and the Study Chair
(optional: will be study specific) and/or ACRIN Publication Committee>>. Any investigator
involved in this study is obligated to provide ACRIN with complete test results and all clinical
data obtained from the participating in this protocol. Investigators will follow ACRIN
Publication Policy (available on the web at http://www.acrin.org/pubpolicy.html).
16.0
INSTITUTIONAL AUDITS
The investigator will permit study-related auditing and inspections of all study-related
documents by the EC/IRB, government regulatory agencies, and ACRIN. The investigator will
ensure the capability for inspection of all participating site’s study-related facilities (e.g. imaging
center, satellite sites). The investigator will allocate adequate time for these activities, allow
access to all study-related documents and facilities, and provide adequate space to conduct these
visits.
Institutional on-site audits will be completed within <<timeframe: depending on accrual goal,
the duration of study; if timeframe is not specified, it will default to 18 months after first
participant enrollment>> of each site’s enrollment of its first ACRIN participant. Subsequent
audits will be scheduled per the outcome of the initial audit. <<Note: audits can be more
frequent and conducted on a yearly basis at the discretion of the protocol team. >> The audits
will be conducted per procedures established by the Cancer Imaging Program (CIP) of the NCI.
Instructions for preparation for the audit visit will be sent to the site prior to the scheduled audit
visit. These instructions will specify which participant case records will be reviewed during the
audit. On-site records will be verified against the submitted form, and the findings will be
recorded on specially prepared audit reports. Major discrepancies will be forwarded to the
appropriate oversight body within ACRIN. IRB procedures, approvals, and consent forms will
also be reviewed at the time of the audit visit. The ACRIN Audit Manual is available online at
www.acrin.org.
To help sites prepare for audits and assure that the investigator and the research staff maintain
records appropriately, the ACRIN data management and auditing departments will offer training
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to sites. This training will cover all aspects of data collection, including special instructions to
obtain and file the various source documents needed to verify the accuracy of submitted data for
this trial. Please refer to the study-specific protocol audit guidelines for details.
16.1
Source Documents
Source data are found in all information, original records of findings, observations, or
other activities in a clinical trial necessary for the reconstruction and evaluation of the
trial. Source data are contained in source documents. Source documents represent the
first recording of any observations made or data generated about a study participant while
he or she is enrolled in a clinical trial. Source documents for each study participant
substantiate the data that are submitted to ACRIN.
Source documents must verify the eligibility criteria and data submitted on all case report
forms (CRFs). If an item is not mentioned (e.g., history and physical with no mention of
a psychological condition), it will be assumed it is not present.
Research records for each case should contain copies of the source documents for the
data reported to ACRIN. If data is abstracted from medical charts that are not filed at the
investigative sites (e.g. hospital charts), copies of these records should be filed in the
research chart. However, every attempt must be made to obtain all records/charts that
were used to abstract any study data for this protocol at the time of the audit visit. This
will prevent any discrepancies and the inability to verify the document and the data
reported.
16.2
Case Report Forms
Case report forms (CRFs) are the primary data collection instruments for the study. All
data requested on the CRFs must be recorded, and any missing data must be explained. If
a space is left blank because the procedure was not done or the question was not asked,
“N/D” must be noted. If the item is not applicable to the individual case “N/A” must be
noted. All entries must be printed legibly in black ink on the paper case report forms. In
the event of any entry errors, corrections must be made by drawing a single straight line
through the incorrect entry, writing the initials of the person making the correction,
recording the date when the correction is being made, and entering the correct data
above the strike through. Do not use white out or an eraser.
Data elements that are extracted from the medical record (such as participant history or
official clinical interpretations of images, pathology, or surgery results) and recorded on
the case report forms (CRFs) will be audited against the appropriate component of the
medical record. Data elements gathered from signed participant questionnaires may be
documented on the CRF. The image interpretation data required by the study that is a
more detailed extraction of information from the image and is not typically documented
in the standard radiology report may be recorded on the CRF and is accepted as source
documentation if signed by the Investigator. At the time of audit, the auditor will verify
the occurrence of the imaging examination, the reader, and the date on which the exam
took place from the medical record. Any use of an approved CRF as source
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documentation requires that the CRF be signed and dated and refer to the source of
the information (participant questionnaire, CT, MR, etc.).
Any use of CRFs as source documentation when the protocol has designated the source
data will be medical record documentation will be considered a deficiency.
16.3
17.0
Institutional Review Board
Sites must obtain local IRB initial approval. Prior to subject registration, a copy of the
IRB approval letter for the protocol and the informed consent form must be sent to
ACRIN, along with a copy of the IRB approved informed consent form. Investigator will
provide a copy(s) of IRB approval letter(s) for any amendment(s), and copy(s) of annual
renewal(s).
STATISTICAL CONSIDERATIONS
(Depending on the protocol, Sections 17.0 and up will be study-specific and include statistics.
As many sections as needed can be added.)
These following sections must be included.
17.1
Study Design and Endpoints
Specify the general study design and primary and secondary endpoints.
Specific Aims and Analysis Plans
This section should re-state specific aims and present a brief analysis plan.
17.2
Sample Size/Accrual Rate
Specify the projected sample size and accrual rate.
The standard statement below may be utilized or modified:
The planned sample size is <<####>> participants at <<###>> institutions, to be
accrued over <<#>> years.
17.3
Power Consideration/Stratification Factor
Specify any power consideration or any planned patient stratification factors.
17.4
Reporting Guidelines
Describe how the study will be monitored for completeness, accuracy, and quality of data
and how often the data will be reported.
The standard language below can be utilized or modified:
Routine reports for this protocol will be included in the ACRIN Biostatistics Center MidYear and Year End Updates and will be provided to oversight bodies, including DSMC
for review during each of its twice-yearly meeting.
Routine reports will include:
 Accrual and participant characteristics
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 Timeliness and completeness, eligibility and protocol compliance, and outcome data
 All reported adverse events
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REFERENCES
This is the bibliography section for any information and publications cited in the protocol. It should be
organized as any standard bibliography page.
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APPENDIX I
ACRIN #
SAMPLE CONSENT FOR RESEARCH STUDY
[Note: ACRIN does not monitor compliance with the Health Insurance Portability and Accountability Act
(HIPAA); that is the responsibility of local IRBs. Local IRBs may choose to combine the authorization elements
in the informed consent, or they may choose to keep authorization separate. Information on ACRIN’s HIPAA
policy, as well as a template for HIPAA authorization, can be found at www.acrin.org.]
Protocol Title:
Insert the title of the protocol
You are being asked to be in this trial because [reason]. This is a clinical trial (a type of
research study) run by the American College of Radiology Imaging Network (ACRIN)
and funded by the National Cancer Institute (NCI). Clinical trials include only
participants who choose to take part. Please take your time to make your decision. You
may discuss it with your family and friends. <<OPTIONAL (if it is not a cancer trial):
The National Cancer Institute (NCI) booklet “Taking Part in Clinical Trials: What
Cancer Patients Need To Know” is available to you. >>
You are being invited to participate in this research study. You are being asked to volunteer
because you meet the requirements to enroll into this study. Include some information about
the study, such as the population or disease/indication. Your participation is voluntary, which
means you can choose whether or not you want to be in this study. Before you make a decision
you will need to know what the study is about, the possible risks and benefits of being in this
study, and what you will be asked to do in this study. The research team is going to talk to you
about the study, and you will be given this consent form to read. You can discuss it with your
family, friends, or family doctor. You may find some of the medical language difficult to
understand. Please ask the study doctor and/or research staff about this form or if you have any
questions. If you decide to do this study, you will be asked to sign and date this form.
WHY IS THIS STUDY BEING DONE?
This section should include a detailed and clear explanation of the research and that the
device or diagnostic treatment is experimental/investigational. It can explain the device
or the diagnostic treatment has been approved for different indication, if applicable.
The purpose of this study is to…
[Applicable text:]
Phase 2 studies:
Find out what effects (good and bad) INTERVENTION has on
you.
Phase 3 studies:
Compare the effects (good and bad) of the INTERVENTION with
COMMONLY-USED INTERVENTION on you to see which is
better.
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This research is being done because…[Explain in one or two sentences.]
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?
This section include the total number of study participants to be enrolled in the study, how many study
participants will be recruited from each institution, the estimated number of institutions that will be
participating in this study, the total duration of the study, and the expected duration of the study
participant’s involvement with the study.
About <<total number#>> people will take part in this study.
HOW LONG WILL I BE IN THE STUDY?
We think you will be in the study for <<MONTHS/WEEKS, UNTIL A CERTAIN
EVENT>>. [Where appropriate, state that the study will involve long-term follow-up.]
This study is expected to end after all study participants have completed the visits and all
the information has been collected. This study may be stopped at any time by your study
doctor, ACRIN, Food and Drug Administration (FDA), or National Cancer Institute
(NCI) without your consent because: [List circumstances, such as in the participant’s
medical best interest, funding is stopped, drug supply is insufficient, participant’s
condition worsens, new information becomes available.]
For your health or safety
For not following study instructions
For study administrative decision by ACRIN, the study doctor, FDA or NCI
These actions do not require your consent, but you will be informed of any of these
decisions if such a decision is made.
You can stop participating at any time. However, if you decide to stop participating in the
study, we encourage you to talk to the study doctor and your family doctor first.
Withdrawal will not interfere with your future care.
[Describe any serious consequences of sudden withdrawal from the study.]
WHAT AM I BEING ASKED TO DO IN THE STUDY?
Provide explanation in lay terms. This section should provide an overview of major
procedures and milestones that will be expected of the participant. Then include a full
list of study procedures/tests in lay terms with descriptions of them, number of times each
items will occur, the amount, the radiation exposure, etc.
[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. It is like flipping a coin. A computer
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chooses which group you are put in. Neither you nor the researcher will choose what
group you will be in. You will have an EQUAL/ONE IN THREE/ETC. chance of being
placed in any group.
[For nonrandomized and randomized studies:]
If you take part in this study, you will have the following tests and procedures:
[List procedures and their frequency under the categories below. For randomized studies, list
the study groups and under each describe categories of procedures. Include whether a
participant will be at home, in the hospital, or in an outpatient setting. If objectives include a
comparison of interventions, list all procedures, even those considered standard.]
WHAT ARE THE POSSIBLE RISKS OR DISCOMFORTS OF THE STUDY?
Describe the known risks and/or discomforts that the study participant may experience
during the course of the study and from the study-related procedures and the possible
effects of imaging.
While on the study, you may be at risk for these side effects. You should discuss these
with the researcher and/or your regular doctor. There also may be other side effects that
we cannot predict. Other drugs will be given to make side effects less serious and
uncomfortable. Many side effects go away shortly after the << INTERVENTION>> is
stopped, but in some cases side effects can be serious, long lasting, or permanent.
[List in bullets by regimen the physical and nonphysical risks of participating in the study in
categories of “very likely”, “less likely but serious” and “rare.” Nonphysical risks may include
such things as the inability to work. Highlight or otherwise identify side effects that may be
irreversible or long-term or life threatening.]
Reproductive risks [if applicable; delete or modify language or sections that are not
applicable]: If you are pregnant or nursing or plan to become pregnant during the course
of the study, you cannot take part in this research study. We do not know the effects on
the fetus; breast-feeding baby, or mother-to-be, and this study may cause harm. Because
the <<drugs/imaging>> in this study can affect an unborn baby, you should not become
pregnant or father a baby while on this study. You should not nurse your baby while on
this study.
During the study and for the <<insert the length of time>> after your final treatment,
you need to take safety measures to prevent pregnancy by not having sex or by using
medically accepted method of birth control such as a diaphragm, cervical cap, condom,
surgical sterility, and/or birth control pills. If you or your partner does become pregnant,
you will need to tell your study doctor immediately.
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Ask about counseling and more information about preventing pregnancy. [May include a
statement about possible sterility and attach additional information about contraception,
etc. when appropriate.]
WHAT ARE THE POSSIBLE BENEFITS OF TAKING PART IN THE STUDY?
This section should include statement that there may not be any benefit, direct or indirect, to the
study participant. Describe possible/anticipated benefits that the subject may experience and the
possible/anticipated benefits to society.
If you agree to take part in this study, there may or may not be direct medical benefit to you. We
hope the information learned from this study will benefit other patients with <<insert the
indication being studied>> in the future.
WHAT OTHER CHOICES DO I HAVE IF I DO NOT WANT TO PARTICIPATE?
You may choose not to participate in this study. If you choose not to participate, there
will be no penalty or loss of benefits to which you are otherwise entitled. Your doctor
can tell you more and other possible options of the different available treatments for your
<<insert the indication being studied>>.
WHAT ABOUT CONFIDENTIALITY?
You understand that every attempt will be made by the investigators to keep all the
information collected in this study strictly confidential, including your personal
information. We cannot guarantee absolute confidentiality. Records of your progress
while on the study will be kept in a confidential form at this institution and in a computer
file at the headquarters of the American College of Radiology Imaging Network
(ACRIN). All data sent to ACRIN over the Internet will be coded so that other people
cannot read it. Your personal information may be disclosed if required by law.
You further understand that authorized representatives of ACRIN, the Food and Drug
Administration (FDA), the National Cancer Institute (NCI), the Institutional Review
Board (IRB) of <<Institution>> and other groups or organizations that have a role in this
study will have access to and may copy both your medical and research records due to
your participation in this study. This access is necessary to ensure the accuracy of the
findings and your safety and welfare. If any publication or presentations result form this
study, you will not be identified by name. Results will be reported in a summarized
manner in which you cannot be identified.
Your <<images>> will be kept permanently on file at ACRIN and may be used for
future research. All personal identifiers are removed and replaced with a unique
identifying number.
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WILL I HAVE TO PAY FOR ANYTHING?
This section should include procedures/tests that will be covered by the study. Procedures that
are not covered by the study should include a statement to indicate that they will be paid either
by the patient or a third party payer (insurance, etc.).
Taking part in this study may lead to added costs to you or your insurance company.
Please ask your study doctor about any expected added costs or insurance problems.
You and/or your health insurance may be billed for the costs of medical care during the
study if these expenses would have happened even if you were not in the study, or if your
insurance agrees in advance to pay. You and/or your insurance company will be charged
for continuing medical care and/or hospitalization.
In the case of medical emergency, injury, or illness during this study, emergency medical
treatment is available but will be provided at the usual charge. You and/or your
insurance will be responsible for the cost of the medical care of that illness or injury.
There is no financial compensation that has been set aside to compensate you in the event
of injury.
WILL I BE PAID FOR BEING IN THIS STUDY?
This section should describe any monetary compensation, if subjects are being
compensated for their time and travel. An itemized amount of the total monetary
compensation ($ amount per each visit/procedure or upon completion of the study)
should be documented here. If no compensation is provided, a statement indicating that
is needed in this section. The standard language noted below may be utilized.
You will receive no payment for taking part in this study.
WHAT ARE MY RIGHTS AS A PARTICIPANT?
Taking part in this study is voluntary. You may choose not to take part in the study. If
you decided to participate, you are free to leave the study at any time. Leaving the study
will not result in any penalty or loss of benefits to which you are entitled. Your decision
whether or not to participate in this study will not interfere with your future care.
During the study, we may find out more information that could be important to you. A
Data Safety and Monitoring Board, an independent group of experts, will review the data
from this research throughout the study. This includes information that might cause you
to change your mind about being in the study. If information becomes available from this
or other studies that may affect your health, welfare, or willingness to stay in this study,
we will tell you about it as soon as possible.
At any time, the study doctor may discontinue your participation in this study. The study
doctor may decide to take you off this study if...[include reasons]
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WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?
(This section must be completed by each individual site)
This document explains your rights as a study participant. It you have any questions regarding your
participation in this research study or you have any questions regarding your rights as a research
participant, do not hesitate to speak with your study doctor or anyone listed below.
For additional information about your health or medical emergency, you may contact: Usually the name
of the local hospital information is provided with instructions to study participants to inform the ER
doctor of their participation in a clinical trial.
Name
Telephone Number
For information about this study, you may contact:
Name
Telephone Number
For information about your rights as a research subject, you may contact <<Institution Name>>
Institutional Review Board (a group of people who review the research to protect your rights):
(Provide the name of local IRB contact person)
Name
Telephone Number
WHERE CAN I GET MORE INFORMATION?
You may call the NCI’s Cancer Information Service at:
1–800–4–CANCER (1–800–422–6237) or TTY: 1–800–332–8615
You may also visit the NCI’s Web sites for comprehensive clinical trials information,
http://cancertrials.nci.nih.gov, or the American College of Radiology Imaging Network
Website, www.acrin.org.
ACKNOWLEDGEMENT
When you sign this document, you are agreeing to take part in this study. This means you have
read all the above information, asked questions regarding your participation, and received
answers that you understand to all your questions. You have also had the opportunity to take this
consent form home for review or discussion if you want to.
You willingly give your consent to participate in this study. A copy of this signed consent form
will be given to you. You may also request a copy of the protocol (full study plan).
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Printed Name of Study Participant/
Legal Representative
Printed Name of Person Obtaining Consent
Signature
__________________
Date
Signature
__________________
Date
Consent for Pathology Collection and/or Biomarker specimen: A separate consent can be drafted for
the pathology collection and/or biomarker specimens. It can also be incorporated into the sample
informed consent form.
Assent: Consents for children to confirm a child’s affirmative agreement to participate in research.
Usually IRBs will determine whether the children in the study population are capable of providing
assent by taking into account the ages, maturity, and psychological state of the children involved.
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REGISTRATION/ELIGIBILITY CHECK
ACRIN Institution #
(Page 1 of 2)
_________
ACRIN Case #
________
The following questions will be asked at Study Registration:
1.
Name of institutional person registering this case
(Y) 2. Has the Eligibility Checklist (below) been completed?
(Y) 3. Is the participant eligible for this study?
4. Date the study-specific Consent Form was signed (mm-dd-yyyy)
(must be prior to study entry)
5. Participant Initials (last, first)
6. Verifying Physician (Site PI)
7. Participant’s ID Number (optional; code 99999)
8. Date of Birth (mm-dd-yyyy)
9. Ethnic category
1 Hispanic or Latino
2 Not Hispanic or Latino
9 Unknown
10. Race (check all that apply)
American Indian or Alaskan Native
Asian
Black or African American
Native Hawaiian or other Pacific Islander
White
Unknown
_____________
11. Gender (M/F)
_____________
12. Participant’s country of residence (if other, complete Q18)
1 USA
2 Canada
3 Other
9 Unknown
_____________
13. Other Country, specify (completed only if Q12 is coded other):_______________________
_____________
14. Zip code (U.S. Residents)
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REGISTRATION/ELIGIBILITY CHECKLIST
(Page 2 of 2)
______________ 15. Participant’s Insurance Status
0
1
2
3
4
5
6
7
8
9
___________
Other
Private Insurance
Medicare
Medicare and Private Insurance
Medicaid
Medicaid and Medicare
Military or Veterans Administration
Self pay
No means of payment
Unknown/Decline to answer
16. Will any component of the participant’s care be given at a military or VA
facility?
No
Yes
9
Unknown
___________
17. Calendar base date (mm-dd-yyyy)
___________
18. Date of registration (mm-dd-yyyy)
Protocol-specific eligibility guidelines are added as they appear in Section 5.0, Eligibility Criteria.
Study Participant Signature: _____________________________ Date: __________________________
Completed by:
__________ Date form completed: ___/____/____
(Research Associate, Investigator Designee, or Principal Investigator)
Signature of person entering data onto the Web _____________________________________________
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APPENDIX III
PARTICIPATING INSTITUTIONS
List institutions expected to participate—include at least PI name, institution name, and e-mail address;
may have complete contact info
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Other Appendices as Needed
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