Health Science Center
Clinical Research Center
INVESTIGATOR APPLICATION
Initial Submission Date: _________________
Revision Date: ___________________
Part One – General Information – Please type
1. Project Title:
2. CRC Protocol # (for staff use only): ______
3. Estimated Total # of Individuals to Be Screened: _______ Total Projected Enrollment: ______
4. Project Duration (yrs.): _______
5. IRB Protocol #: ___________
IRB Approval Date: ______________
IRB Approval Status:
Approved
Pending
IRB Expiration Date: __________________
6. Principal Investigator (PI):
Name:
Title:
Department:
Telephone:
FAX:
Pager:
E-mail:
Mailing Address:
7. Responsible physician:
Name:
Title:
Department:
Telephone:
FAX:
Pager:
E-mail:
Mailing Address:
University of TN Health Science Center CRC Investigator Application
Revised 1/30/14
Page 1
8. Study coordinator:
Name:
Title:
Telephone:
FAX:
Pager:
E-mail:
Mailing Address:
9. Co-Investigator(s):
Name
Department
E-mail
Telephone
10. Study site (please check all appropriate boxes):
Methodist University Hospital - Adult Inpatient
Methodist University Hospital - Adult Outpatient
Le Bonheur - Pediatric Inpatient
Le Bonheur - Pediatric Outpatient
MedPlex - Adult Outpatient
MedPlex - Pediatric Outpatient
Regional Medical Center - Adult Inpatient
VA Medical Center – Adult Inpatient
VA Medical Center – Adult Outpatient
Other (please specify):
11. Project category:
A Inpatient admissions or outpatient visits solely for research purposes.
B Inpatient admissions or outpatient visit contain a combination of research and clinical components.
D Inpatient admissions or outpatient visits for an industry-initiated protocol.
12. Inpatient:
Number of subjects per year (include screened failures):
Number of inpatient days per subject per year:
Total inpatient days/year requested:
13. Outpatient:
Number of subjects per year (include screened failures):
Number of outpatient visits per subject per year:
Total number of visits requested per year:
Average duration of outpatient visits (hours):
University of TN Health Science Center CRC Investigator Application
Revised 1/30/14
Page 2
14. Multicenter study?
Yes
No
Clinical Trial Phase
Phase I
Phase II
Phase III
Phase IV
Other (specify):
15. Sources of support
UT account number: ________________________
(Financial Account to be charged for Clinical Research Center
services)
Please indicate all funding sources for this project. List only direct and indirect costs coming to the
investigator at UTHSC. If you are on a Center Grant/Program Project Grant, please list only those costs for
your particular project – not the entire grant. If you are the Program Director for a Center Grant/Program
Project Grant, list only those costs associated with your portion – not the entire grant.
Funding
Source 1
Funding
Source 2
Funding
Source 3
Full Name of Funding Agency:
Direct Costs (current/most recent
yr.):
Indirect Costs (current/most recent
yr.):
Federal Grant or Contract #:
Non-Federal Grant or Contract #:
Funding Status:
Funded
Pending
Funded
Pending
Funded
Pending
Kind of Funding Agency
For CRC Use Only
For CRC Use Only
For CRC Use Only
-
Please submit approved budget and budget justification from internal or external funding
source.
If any part of your study will be funded utilizing industry, please also attach a copy of the
clinical trials agreement/contract.
University of TN Health Science Center CRC Investigator Application
Revised 1/30/14
Page 3
CRU RESOURCE UTILIZATION
16. Nursing requirements - Please describe nursing duties requested. Note: If you plan to use CRC
Nursing Staff, attach a “Subject Inclusion/Exclusion Checklist” for nursing use to be included in patient
record. Contact Research Nurse Director Alice Milem, RN at 516-2212 for questions.
17. Dietary requirements - Please describe. Contact Nutritionist (TBA) at 516-2212, for questions.
18. Informatics support requirements – Please describe.
19. Statistical review report requirements – Please describe .
20.
Ancillary support. Complete the worksheets below. Make certain to include screening visits if
ancillary support is being requested for screening. Please note to include ancillary budget for the
entire project period. Contact Alice Milem, RN Nurse Director at 516-7086 for questions.
BASED ON THE ENTIRE STUDY PERIOD, please complete the following for budget planning:
University of TN Health Science Center CRC Investigator Application
Revised 1/30/14
Page 4
Yearly Enrollment
Projected # of
inpatients
Total # inpatient days
1st year
2nd year
3rd year
4th year
5th year
Projected # of outpatients
Visits per patient
Total # outpatient visits
Ancillary support is for the entire period of the project. Make certain to include screening visits if ancillary
support is required. Do not include items that will be paid from other grant support.
Lab Tests (add rows as # per
needed)
Subject
1
2
3
4
5
6
7
8
9
10
# of Subjects
Out-Patient
# of Subjects
In-Patient
Total # tests
This column for
CRC use only
X-Rays, EKGs, etc.
# per
Subject
# of Subjects
Out-Patient
# of Subjects
In-Patient
Total # tests
This column for
CRC use only
# per
Subject
# of Subjects
Out-Patient
# of Subjects
In-Patient
Total #
This column for
CRC use only
# per
Subject
# of Subjects
Out-Patient
# of Subjects
In-Patient
Total #
This column for
CRC use only
1
2
3
4
5
6
Medications
1
2
3
4
5
6
Medical/Surgical
Supplies
1
2
3
University of TN Health Science Center CRC Investigator Application
Revised 1/30/14
Page 5
4
5
6
7
8
21. Justification of need for CRC resources (Briefly describe why proposed study needs to be
conducted at the CRC):
22. Publications. Any publications resulting from research supported by the CRC must cite the Clinical
Research Center as a contributing source of support. Please submit the publications to Alice Milem, RN
Nurse Director at cmilem@uthsc.edu. Please submit two copies of all abstracts and publications. In
addition, any publicity regarding the conduct (i.e. recruitment) or results of the study should cite the CRC
as well.
University of TN Health Science Center CRC Investigator Application
Revised 1/30/14
Page 6
Part Two – Supporting Information
23. Research protocol with demographic tables. All applications must be accompanied by a research
plan/protocol with hypotheses and specific aims, demographic tables under the human subjects section of
the research plan with a statement about the inclusion of minorities, women and children in the research
project. If any of these groups are excluded, there must be an exclusion justification included in the
protocol. If needed, refer to the Research Plan template.
24. IRB documentation. Please provide the IRB-approved protocol, consent form(s), and IRB approval letter
regarding this research project.
25. Data and Safety Monitoring Plan (DSMP). Please provide the Targeted/Planned Enrollment Table and
the DSMP by completing pages 9-13 of this application. For information about how to complete the form,
please read the DSMP guidelines.
Contact the CRC Nurse Director if you need further assistance in completing this form.
26. Checklist. Please mark each of the following items to indicate their inclusion:

Item:
Completed CRC application form, including completed statistical sections within application.
An electronic version of the protocol, or a Research Plan with abstract, hypotheses and specific aims,
appendices and references, as well as the rationale for subject inclusion/exclusion criteria.
Demographics tables for recruitment within protocol.
Inclusion/exclusion checklist with Y/N boxes.
IRB approved consent form(s) and IRB approval letter.
Other support page (mark “N/A” if not receiving any other support).
Enrollment Table and Data and Safety Monitoring Plan (DSMP) included in the CRC application.
Package inserts or other documentation (e.g., IND, IDE) on study drugs and/or devices administered
(mark “N/A” if not applicable).
Note: Incomplete applications will be returned to the investigator for revision. The CRC staff will contact
you if there are questions. Please contact CRC Program Director Dr. Sam Dagogo-Jack at 448-2608,
or Alice Milem, RN Nurse Director at 516-7086 if questions regarding the application process. Thank
you.
University of TN Health Science Center CRC Investigator Application
Revised 1/30/14
Page 7
Principal Investigator/Program Director (Last, First,
Middle):
1. Targeted/Planned Enrollment Table
Study Title:
Total Planned
Enrollment:
TARGETED/PLANNED ENROLLMENT: Number of Subjects
Ethnic Category
Females
Sex/Gender
Males
Total
Hispanic or Latino
Not Hispanic or Latino
Ethnic Category: Total of All Subjects *
Racial Categories
American Indian/Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
Racial Categories: Total of All Subjects *
University of TN Health Science Center
CRC Investigator Application
Revised 7-12-12
Page 8
Data and Safety Monitoring Plan (DSMP)
University of Tennessee Health Science Center – Clinical Research Center
I.
Protocol Information
Study Title:
Principal Investigator:
PI Department:
IRB #
IRB Original Approval Date:
IRB Current Expiration Date:
(For CRC Staff use only)
CRC #
CRC Approval Date:
II. DSMP Personnel
Names, titles and functions of individuals involved with the DSMP. In addition to the PI, these may include
the research coordinator, research associate, statistician, and/or any study staff that meet regularly to
review study status. If independent or industry-sponsored DSMB is being utilized, provide details of
members/roles here.
Name
Title /Role
Principal Investigator
Co-Investigator
Department
III. Purpose
The Data and Safety Monitoring Plan (DSMP) is established to ensure the safety of research participants
and the integrity of the study data.
University of TN Health Science Center
CRC Investigator Application
Revised 7-12-12
Page 9
IV. Data and Record Safety/Confidentiality/Training
Records, filed in the IRB office, verify that all research project personnel have completed training in the
protection of human research subjects in accordance with the guidelines of the U.S. Department of Health
and Human Services (DHHS) and the Office for Human Research Protection (OHRP).
A. Medical Records. Example: All information about subjects will be protected in accordance with
very strict safeguards. Biological samples and questionnaire results will be assigned an
anonymous code by the research nurse. The research nurse at each study site will maintain
original records identifying subjects for the purpose of tracking subject recruitment and allowing
the later review of patient records to verify their accuracy, the proper application of
inclusion/exclusion criteria, and the existence of medical conditions not apparent at the time of
delivery. A printed copy of these records will be maintained by the PI to prevent irretrievable loss
of information. Unique patient identifiers are never stored in an electronic form. Both the research
nurses and PI have locked file cabinets bolted to their office walls in which the printed records
containing patient identifiers will be stored.
B. Electronic Data. Example. All electronic files (e.g., database, spreadsheet, etc.) containing
identifiable patient information will be password protected. Any computer hosting such files must
have a password to prevent access by un-authorized users. Furthermore, a password-protected
screen saver will be installed and configured to activate ten minutes after the computer has been
idle.
V. Assessment of Level of Risk
In accordance with the Code of Federal Regulations (45 CFR 46.102, 46.111, & 46.406) defined risk in
this study is (check one):
O
Minimal Risk: This study is designated minimal risk for adults, i.e., the probability and magnitude
of harm or discomfort anticipated in this research proposal are not greater than those ordinarily
encountered in daily life or during the performance of routine physical and psychological
examinations or tests. This category includes protocols that pose “no greater than minimal risk”
according to federal regulations.
O
Low Risk: This study involves a minor increase over minimal risk, i.e., the intervention or procedure
presents experiences that are reasonably commensurate with those inherent in actual or expected
medical, dental, social, or educational situations.
O
Moderate Risk: Moderate risk studies exceed the minimal risk; however, risks are considered reasonable
in relation to anticipated benefits, if any, to the subjects, and the importance of the knowledge that is
reasonably expected to result
O
High Risk (All high risk studies require a formal entity [e.g., a DSMB] for data and safety
monitoring). The study risk is greater than minimal, and there is no prospect of direct benefit to
the individual subjects, but the research is likely to yield generalizable knowledge about the
subject's disorder or condition. High risk studies may include clinical trials using investigational
agents or devices, including Phase I clinical trials and some Phase II clinical trials
2.
VI.
Periodic Safety Review/Report
University of TN Health Science Center
CRC Investigator Application
Revised 7-12-12
Page 10
A. The following information will be considered in the periodic safety report:







Summary of adverse events.
Analysis of outcome data and its relationship to potential changes in study design.
Number of subjects who have enrolled in the study.
Number of subjects who have completed the study.
Dropout rates and reasons for the dropouts.
Hypothesis validation
Any other relevant information
B. If the study is utilizing a DSMB or formal monitoring entity, then we request a description
of this (e.g. frequency of meetings, what is being reviewed? [AEs, enrollment, etc.] or
comment regarding their intention to follow this plan or other attached DSMP,
dissemination of meeting concerns/comments or minutes, etc.)
C. Periodic report monitor and schedule:
Level of Risk
Minimal/Low
Risk Studies
Moderate/High
Risk Studies
O
O
O
O
O
O
O
Monitor (check all that apply)
PI
Co-Investigator
DSMB or other formal monitoring entity
Local Monitor (specify here):
O
O
O
O
Frequency
Annually
Semi-annually
On an occurrence basis
Other (specify here):
DSMB-local
O
DSMB- external
O
Other formal monitoring entity (specify here): O
O
Annually
Semi-annually
On an occurrence basis
Other (specify here):
D. All Periodic Safety Review/Reports will be sent to the IRB, the Scientific Advisory Board (SAB), and
the following designated entity (check any that apply):
O
O
O
O
O
O
External DSMB
CRC Research Subject Advocate (required if utilizing CRC resources)
NIH
FDA
Other Governmental Agency: (specify): __________________________________________
Sponsor: (specify): ____________________________________
VII. Toxicity Assessment.
Risks and Plans To Minimize Risk. Please indicate all the potential risks inherent in the study
University of TN Health Science Center
CRC Investigator Application
Revised 7-12-12
Page 11
Physical Risks:
Psychological Risks:
Social or Legal Risks:
There is a very small risk of unintended disclosure of confidential information to parties outside the
research context that might affect insurability or employability. However, this risk will be minimized by
appropriate confidentiality measures such as those described above.
VIII. Reporting of Adverse Events
The PI or his/her delegate is responsible for collecting and recording all clinical data. As these results are
collected, all toxicities and adverse events will be identified, graded for severity and assigned causality,
reported to the required entities, and compiled for periodic review. The PI will evaluate all AEs and
determine whether the adverse event affects the risk/benefit ratio of the study and whether modifications
to the protocol or informed consent form are required. All adverse events will be reported according to
UTHSC CRC guidelines.
The PI’s signature above verifies that he understands the local, state, and federal reporting requirements
for this study.
Adverse event coding. The following codes will be used for reporting all adverse events:
Grading of adverse events (0-1 non-serious; 2-5 serious)
0
No adverse event or within normal limits
1
Mild adverse event
2
Moderate adverse event
3
Severe adverse event resulting in a) hospitalization, b) persistent or significant
disability/incapacity
4
Life-threatening or disabling adverse event
5
Fatal adverse event
Attribution/Causality
1
Certain: adverse event clearly related to participation in research study
2
Probable/likely: Adverse event likely related to study participation
3
Possible: Adverse event may be related to study participation
4
Unlikely: Adverse event is probably not related to study participation
5
Unrelated: Adverse event is not related to study participation
University of TN Health Science Center
CRC Investigator Application
Revised 7-12-12
Page 12
Reporting requirements
Unexpected, serious adverse events must be reported to the IRB and the Clinical Research Center
(Nurse Director) within one working day of study staff becoming aware of the incident. A followup written report must be submitted to the Nurse Director within 5 days following the original
notification, if complete information was not available at the time of the initial report. Expected serious
adverse events must be reported to the CRC (Nurse Director) within seven (7) calendar days.
Unexpected non-serious adverse events must be reported in writing to the CRC (Nurse Director)
within fourteen (14) calendar days. Expected non-serious events must be reported in writing to the
CRC Nurse Director on a quarterly basis.
Protocol violations must be reported to the IRB and the CRC (Nurse Director) within 5 days of their
occurrence. A corrective action plan must accompany the report of the violation.
IX. Study Suspension:
If it has been determined, for any reason, that there will be a suspension of this study, the following plan
for suspension should be followed:
O
O
O
O
O
Suspend enrollment of new subjects but continue intervention and monitoring of previously
enrolled subjects
Suspend study therapy or intervention and continuing monitoring
Suspend all but monitoring activities
Suspend experimental procedures and continue monitoring
N/A (explain)
X. Conflict of interest Statement
Is there a possible conflict of interest with this study? O Yes O No
If yes, have you filed your conflict of interest with the Office of Research Compliance? O Yes O No
XI. Other factors
None
University of TN Health Science Center
CRC Investigator Application
Revised 7-12-12
Page 13