Research
OFFICE OF CLINICAL RESEARCH ADMINISTRATION (OCRA)
Study Review & Initiation
The Research Office has established a new process devoted to the review of clinical trial agreements, grants and sub-contracts.
The first step in initation of any study that involves Human Subjects is submission of the required forms & documents for each category (see below) to OCRA . OCRA will review all clinical trial agreements (CTAs), grants and sub-contracts for study feasibility and compliance in billing prior to initiation of review by ORSP, Legal, and Grants & Contracts. The purpose of the review is to assist the faculty in meeting compliance requirements, developing billing plans & budgets, and to decrease duplication of effort.
PROCEDURE CATEGORIES (click to go to section)
IMPORTANT REMINDER!
Each time you plan to initiate or modify a study, please refer to the below UPDATES for the most current versions of OCRA forms. Forms change frequently so please check each time you initiate or modify a study:
UPDATES
Current Feasibility Form Version: V8 (as of 4/25/11)
Current bSOE Version: V8 (as of 4/25/11)
Chart Review Registration Form Version: V8 (as of 4/25/11)
Subject Registration Form Version: V8 (as of 4/25/11)
A. PROCEDURES FOR INITIATING CLINICAL TRIAL AGREEMENTS (CTAS) INVOLVING HUMAN SUBJECTS
(see separate instructions below for Grants)
Prior to STEP 1 for study initiation: You must have an approved Confidentiality Agreement Signed by Legal prior to initiating this process
STEP 1.
E-mail Copies of the Following Documents to OCRA Review@umdnj.edu
a. Copy of 1st draft of GAFA (needed to associate a GAFA # with each study for tracking purposes)
b. Copies of Completed Financial Disclosure Forms (FDFs)
c. Completed Feasibility Form
Click here to download Study Feasibility Form ( Current Version: V8 )
d. OCRA Budgeted Schedule of Events (bSOE)
Click here to download bSOE ( Current Version: V8 )
e. Draft of Contract including sponsor budget
f. Draft of IRB Protocol & Consent Form
g. Include any supporting documentation on Feasibility Form checklist (FDA approval letter etc.)
You will receive an email confirmation of receipt of the study initiation documents by OCRA with a request for any missing information. Review of your submission will not begin until all forms & documents are received and properly completed. Please only send email or faxed copies of documents, DO NOT SEND ORIGINALS.
STEP 2.
Once the feasibility of the CTA is established:
OCRA approves feasibility & and forwards CTA to Legal Department
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For Non-Qualifying Trials, all costs of the Trial, including routine care, will have to be covered under the by the Sponsor. This may require further negotiations.
- For Qualifying Trials, OCRA will forward email an electronic copy of the CTA to the Legal Department to initiate review of contract. The PI will receive e-mail notification that legal review has been initiated.
OCRA meets with study team to review budget
Once finalized, OCRA forwards final approved budget to Legal & PI
STEP 4.
PI submits to ORSP:
- ORIGINAL GAFA (with G&C signature page)
- ORIGINAL FDFs
- Final CTA negotiated by legal with OCRA approved budget
STEP 5.
ORSP Forwards GAFA, FDFs, Final CTA & Budget to Legal Department for FINAL SIGNATURES
B. PROCEDURES FOR INITIATING GRANTS AND SUB-CONTRACTS INVOLVING HUMAN SUBJECTS
Grants and sub-contracts that involve human subjects must be submitted for review at least 12 days prior to the deadline for submission. The review of clinical research grant budgets, and determination of study feasibilty (including availability of required hospital and medical school resources) may require a significiantly longer period of time for review than grants that do not involve human subjects. The 12 days advance notice is absolutely required in order to ensure review and sign off on time for submission. Clinical Research Grants and Sub-Contracts submitted to the office after the 12 day advance deadline may not be reviewed.
12 Days Prior to Deadline for Grant or Sub-Contract:
FOR GRANT OR SUB-CONTRACT REVIEWS THAT INCLUDE HUMAN SUBJECTS AT A NJMS/UH SITE AND/OR THE COLLECTION OF HUMAN SPECIMENS FORWARD THE FOLLOWING DOCUMENTS TO: OCRA Review@umdnj.edu & njms-research@umdnj.edu
a. Copy of 1st draft of GAFA (needed to associate a GAFA # with each study for tracking purposes) |
b. Completed Feasibility Form Click here to download Study Feasibility Form ( Current Version: V8 ) |
c. OCRA Budgeted Schedule of Events (bSOE) Click here to download bSOE ( Current Version: V8 ) |
d. Abstract |
e. Budget Justification |
| f. Human Subjects Section and 1st draft of protocol if available |
FOR GRANTS OR SUB-CONTRACTS THAT INVOLVE THE PURCHASE OF HUMAN SPECIMENS AND/OR ARE PART OF A PROJECT WHERE HUMAN SUBJECTS ARE INVOLVED AT A SITE OTHER THAN NJMS/UH
SUBMIT FOLLOWING DOCUMENTS TO ORSP AT (973) 972-7766/4568 or njms-research@umdnj.edu or Click here to ORSP Grant Administrator Assignments
