
Office of Clinical Research
Internal Resources
OCR Industry Sponsored Study Guide
About the OCR
The Office of Clinical Research (OCR) is a central office in the Perelman School of Medicine (PSOM) designed to support the management and conduct of clinical research while promoting compliance. This is accomplished through standardizing the approach to clinical research across the various research centers and departments in the Perelman School of Medicine, and supporting investigative teams through regulatory and operational assistance, and enhancements in study management and oversight.
Contact Us
University of Pennsylvania
Perelman School of Medicine
8041 Maloney Building
3400 Spruce Street
Philadelphia, PA 19104
215-662-4484
215-573-8996 (fax)
ocr@pobox.upenn.edu
https://www.med.upenn.edu/ocr/
How to use this Guide
This guide is intended to be used in conjunction with the Penn Manual, a web-based resource and guidance document on how to conduct clinical research at Penn. This document gives an overview of required steps for any given Industry Sponsored Clinical Trial. Throughout the guide there are links to forms and Penn Manual pages to help you navigate through Penn Medicine’s research landscape.
7 Steps to an Industry Sponsored Clinical Trial-Quick Reference Guide
Listed below are the basic functional steps to help Investigators and their team navigate clinical research from start-to-finish.
1. Protocol Selection | → Study Start-up Phase |
2. Study and Site Feasibility Assessment | |
3. Regulatory Submission and Approval | |
4. Legal and Financial Review and Approval | |
5. Site Activation | |
6. Study Execution | → Active Enrollment Phase |
7. Study Closure | → Close Out Phase |
The Business Administrator (BA) and Clinical Research Coordinator (CRC) should communicate routinely throughout the lifecycle of the study to make sure that the finances of the study are accurate.
A summary of their collaboration is depicted below.
Key Reviewing Groups
IRB — Institutional Review Board
CTSRMC — Clinical Trials Scientific Review and Monitoring Committee (for oncology trials)
CTCU — Clinical Trial Contracting Unit
CISC/OVPR — Conflict of Interest Standing Committee/Office of the Vice Provost of Research
Key Research Roles
Key Research Roles and their responsibilities can be found here.
1. Protocol Selection
Activity | Comment |
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PI is approached by Sponsor for study consideration |
PI needs to determine if there are:
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Sponsor requires a Confidentiality disclosure agreement (CDAs) to be signed before protocol is provided |
CDAs to enable review of protocols from companies are reviewed by an Office of General Counsel lawyer and signed by the Executive Director in ORSS and/or the Principal Investigator (based on sponsor’s requirements). |
2. Study and Site Feasibility Assessment
Activity | Comment | References |
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Confirm Feasibility |
Make determination to proceed after considering the following:
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Obtain all protocol information from sponsor |
Obtain protocol, case report forms, investigational product information, monitoring plans, logs, etc. This material is referred to altogether as the Regulatory Binder or Study Administrative File. |
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Budget Evaluation |
For corporate-sponsored studies, budget negotiation is between the sponsor and the site (specifically the study team’s BA). The Sponsor will usually offer a budget template to the site. The BA is responsible for the budget, but OCR Finance is available to assist with budget negotiations, if needed. |
3. Regulatory Submission and Approvals
To take place concurrently with Step 4
Instructions for Requesting Parallel Review
Activity | Comments | References |
---|---|---|
Review all elements needed for submission, such as:
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Make sure that all applicable parties are included, such as:
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Elements of Informed Consent Form |
* Obtain UPCC Number |
Cancer-related protocols require a UPCC# in addition to an IRB#. PennCTMS (commonly referred to as Velos) is the Clinical Trials Management System (CTMS) for all cancer-related trials. You will need access to PennCTMS to submit a cancer-related protocol for initial review.
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*Monitoring Plan for Industry Sponsored or Cooperative Group Sponsored Studies |
The PI must play a role in the ongoing monitoring and oversight of his/her protocol. If the protocol is cancer-related, a Monitoring Plan must be submitted to the DSMC to gain CTSRMC approval. If a Medical Monitor will monitor the protocol, s/he cannot also be the PI. |
DSMC Sponsored Monitoring Plan Form |
4. Legal and Financial Review and Approval
To take place concurrently with Step 3
Instructions for Requesting Parallel Review
Activity | Comments | References |
---|---|---|
Budget building and negotiation |
Budget negotiation may be the responsibility of the investigator, CRC, BA or other research staff; budget approval is the responsibility of the business office.
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To obtain access to the Cost-Finder system, register with the Clinical Research Registry Contact OCR if you would like assistance with budget development |
Review protocol procedures for standard of care vs. research |
Standard of care means: usual and reimbursable cost. Sponsors will often provide reimbursement language in the contract. The study team (CRC/BA/PI) is responsible for providing an accurate assessment by filling out the Prospective Reimbursement Analysis (PRA). |
Prospective Reimbursement Analysis (PRA) Form See Below for summary of CRC/BA co-responsibilities |
Use of Device in the OR |
If the protocol involves the use of an investigational agent/device within the Operating Room, please contact surgical services. |
Contact: |
Financial Disclosure |
FIDES is a web-based application to report financial interests and relationships related to participation in specific research projects.
It is recommended that you notify OVPR once this is finalized. |
For Help e-mail: OVRP |
Contract |
Non-budget contractual terms are negotiated by CTCU; requests are submitted via a parallel review form; once non-budget terms and budget are negotiated and internal school approvals are obtained, the contract is signed. For additional information contact CTCU. |
Contact CTCU |
Request Research Billing Number (RBN) |
Establish billing procedures
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5. Site Activation
Activity | Comments | References |
---|---|---|
Assure that all paperwork is completed, submitted, and filed appropriately |
Keep regulatory files in a secure area per Sponsor requirement. Sponsors usually provide information on how they want the regulatory binder organized. Determine the following:
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Site initiation visit (SIV) |
This can be an on-site visit, or an investigator meeting. |
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Study supplies/drug/device |
If the Sponsor has agreed to provide supplies/drug/device, they will be shipped around the time of study activation. Make sure the space is secure and meets the requirement for storage (light/humidity/temperature, etc).
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Complete site training |
Copy and distribute all relevant study materials to study personnel as defined in the Delegation of Responsibility Log |
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Protocol training |
Develop a training agenda for study staff not trained by the sponsor. Document training.
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6. Study Execution
Activity | Comments | References |
---|---|---|
Screen and Recruit Subjects |
Sites should have agreed upon screening method.
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Subject follow-up |
The time and procedures for subject follow-up will be determined by the study protocol’s endpoints. All follow-up assessments and documentation should be completed, recorded, and sent to Sponsors per protocol. Re-consent as needed. |
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Subject Payment |
Submit subject remuneration/ reimbursement to BA in a timely manner. Document payment submission. |
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Adverse Event (AE)/Serious Adverse Event (SAE) Management |
Procedures for handling AE and SAE will vary by Sponsor. Make sure you know of the proper reporting process for your study.
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Monitoring |
The Sponsor may send a Study Monitor (also known as a CRA) periodically to review and assess the progress of the study. |
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Annual Review |
Most reviewing entities require that you submit a Continuing Review form annually. Submit items to Sponsor/CRO before submitting to IRB and other reviewing entities. |
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Protocol Modification |
Modifications can range from changes in the primary or secondary outcomes, changes in follow-up procedures. Or just the addition/removal of staff. Distribute submissions and final approvals to all relevant reviewing entities, staff, and Sponsor contacts. |
Submitting Modification/Amendments. Modification- how to submit to the IRB. |
Deviation |
Deviations are a one-time, unintentional action that does not follow the protocol. Sponsors may have their own reporting requirements. Forward all documentation to relevant reviewing entities. Determine whether or not a protocol amendment is needed to prevent further deviation. |
Documentation and Reporting Deviations Deviation - how to submit to the IRB. If the deviations compromise the safety and welfare of subjects, it must be reported within 10 business days to the IRB. |
Exception |
Exceptions are a one-time, intentional action that does not follow the protocol but is approved by the IRB prior to the occurrence. Speak to your sponsor first before submitting an exception to the Penn IRB. Circulate to all relevant reviewing entities and study staff members. |
Exception – how to submit to the IRB. You must get the Exception approved by both the IRB and Sponsor before the exception from the protocol is implemented. |
7. Study Closure
Activity | Comments | References |
---|---|---|
Notify Reviewing Entities |
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Investigational Product Management |
Complete Investigational Product inventory assessment.
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Document Collection and Archiving |
The University Records Center provides a service to dispose or store research study documents.
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University Records Center |

SUMMARY OF STEPS
CRC-BA Responsibilities
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