As part of the Quality Assurance Program, JOHRP offers assistance in the creation and maintaining of study/regulatory and patient binders for clinical research studies. While the Quality Assurance Team is more than happy to meet with and assist any study personnel in their documentation methods, JOHRP has provided all the tools needed to create your own binder using the documents below. Documents for both study/regulatory and patient binders have been provided.
Jefferson Office of Human Research Protection
Leadership
Name:
Walter Kraft, MD
Position:
- Director, Jefferson Office of Human Research Protection
- Director, Clinical Research Unit
- Professor, SKMC Department of Pharmacology, Physiology and Cancer Biology
Email:
Walter.Kraft@jefferson.edu
Contact Number(s):
* Secure links
For Research Activities
Name:
Larry Harshyne, PhD
Position:
Acting Institutional Official, Human Subjects Research, Animal Research
IRB Forms & Submission Materials
The following forms and templates should be used as applicable when submitting to the IRB. Forms should be completed in their entirety and should be uploaded to iRIS as a PDF. Uploading word documents to iRIS may cause distortion and lead to a delay in review. Note: Password protected documents are not accepted by iRIS.
| FORM | REVISED | DESCRIPTION |
|---|---|---|
| HIPAA Authorization (DOCX) | 4/12/19 | Authorization to use and/or disclose PHI |
| OHR- 8 Informed Consent Template (DOCX) | 5/21/26 | Informed Consent |
| Instruction Manual for Consent Form (PDF) | 3/27/25 | Instruction Manual for the Consent Form for a Research Study |
| OHR-8F (DOCX) | 7/2006 | Subject Recruitment Letter |
| OHR-8H (DOCX) | 1/20/20 | Verbal Consent With Optional Use of Disclosure of PHI |
| OHR-8K (DOCX) | 2/27/19 | Consent Form Template for NCI CIRB Studies Only |
| OHR-8S Attestation (PDF) | 12/9/19 | Certificate of Translation for all OHR-8S forms. |
| OHR-8S (English) (PDF) | 11/4/19 | Short Form Consent (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Albanian) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Arabic) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Bengali) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Cambodian) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Chinese-Simple) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Chinese - Traditional) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Farsi) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (French) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Greek) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Gujarati) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Haitian Creole) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Hindi) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Indonesian) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Italian) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Korean) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Polish) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Portuguese - Brazilian) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Russian) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Spanish) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| OHR-8S (Vietnamese) (PDF) | 11/4/19 | (Contact IRB and See OHR Policy IC 705 Before Using) |
| FORM | REVISED | DESCRIPTION |
|---|---|---|
| OHR-10 (DOCX) | 2/2018 | Only Use if You Do Not Have Access to iRIS. |
| OHR-20 (DOCX) | 8/2014 | Only Use if You Do Not Have Access to iRIS. |
| FORM | REVISED | DESCRIPTION |
|---|---|---|
| Research Protocol Template (DOC) | 11/2010 | For use with investigator-initiated trials (IIT) in addition to the OHR-2 |
| Sidney Kimmel Comprehensive Cancer Center Protocol Templates | For use with investigator-initiated trials (IIT) involving cancer in addition to the OHR-2. Please visit the SKCCC ONE page for more information. | |
| TransCelerate Biopharma Inc. Protocol Template | Use link to access the Basic Word Edition Template and Guidelines | |
| Protocol Development for Investigator--Sponsored Clinical Studies | 01/2026 | A protocol development how-to published in Clinical and Translational Science April 2025. |
Study/Regulatory Binder Documents
| Document | Description |
|---|---|
| Divider Tabs (DOC) | The divider tab inserts needed for the binder |
| Binder Section Descriptions (DOC) | A sheet for each section indicating what should be stored in that section |
| Screening and Enrollment Log (DOCX) | List of all screened/enrolled subjects |
| Delegation of Authority Log (DOCX) | List of responsibilities assigned to each team member |
| Biological Specimen Tracking Log (De-identified) (DOC) | De-identified tracking log for biological specimens |
| Biological Specimen Tracking Log (Identifiable) (DOC) | Identifiable tracking log for biological specimens |
| Training Log (DOCX) | List of training completed by team members |
| Unanticipated Problems Log (DOCX) | List of unanticipated problems |
Patient Binder Documents
| Document | Description |
| Patient Binder Contents Sheet (DOC) | List of some patient binder contents |
| Informed Consent Checklist (DOC) | Checklist to help document all aspects of the consent process |
| Investigational Product Accountability Log (DOC) | Documents test article dispensation and return |
| Documentation of Subject Unblinding (DOC) | Documents when a subject's treatment must be unblinded |
| Adverse Event Log (DOCX) | List of adverse events |
| FORM | REVISED | DESCRIPTION |
|---|---|---|
| Monitoring Plan | 1/10/25 | Plan for monitoring by a clinical trial monitor, not a DSMB |
| DSMB Charter | 1/10/25 | Charter template for DSMB |
| DSMB Summary Report | 1/10/25 | Template for Summary Report for DSMB meetings |
| Protocol Language Suggestions for Medical Monitors and DSMB | 1/10/25 | Language to include in the protocol regarding having a Medical Monitor and DSMB |
| FORM | REVISED | DESCRIPTION |
| Unaffiliated Investigator Agreement (DOC) | 5/6/19 | For use with investigators who have no institutional affiliation (with Jefferson or other institutions). |
| SMART Letter of Acknowledgement (DOCX) | 7/30/26 | Used for IRB reliance situations where IRB review will be ceded under the SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement. Please consult the IRB Reliance webpage or email jennifer.polizzi@jefferson.edu. |
| IAA (DOCX) | 9/4/24 | Used for IRB reliance situations where IRB review will be ceded from a non-SMART IRB institution. Jefferson will serve as the IRB of Record. Please consult the IRB Reliance webpage or email jennifer.polizzi@jefferson.edu. |
| Nemours IRB Authorization Form (DOCX) | 8/28/24 | A template used by Jefferson Personnel when submitting to Nemours IRB. Please include in your Airtable submission. |
| Local Context Questionnaire for Site Relying on Jefferson IRB (DOCX) | 7/30/26 | Jefferson Relying on Site Survey for Multicenter Studies |
| Statement of Work Template: IRB of Record (DOCX) | 7/30/26 | This form is used to describe activities of the external sites/investigators when Jefferson is the IRB of Record for a multi-site study. |
| Statement of Work Template: Cede/Relying (DOCX) | 7/30/26 | This form is used to describe activities of the Jefferson investigator(s) when Jefferson is ceding review to another IRB. |
| External IRB HRPP Assessment Tool (DOCX) | 7/30/26 | This form is used to the strength of an HRPP when Jefferson is requested to rely on an IRB that is not accredited. |
| Certification of Local Context for a Multi-Site Study under Single IRB Oversight: New Site Addition (DOCX) | 7/30/26 | This form is used to document and certify that research conducted at a site relying on Jefferson has been reviewed for local policies, laws, and regulations. |
| Certification of Local Context for a Multi-Site Study under Single IRB Oversight: Continuing Review (DOCX) | 7/30/26 | This form is used to document and certify that investigators conducting research at a site relying on Jefferson have been properly trained and are qualified to conduct Human Subjects Research. |
| Overall PI Checklist (DOCX) | 9/4/24 | This checklist should be reivewed by the PI in order to review the responsibilities in assuming the role of overall PI for a study under single IRB ovesight. A signed copy should be submitted via iRIS with the amendment submission. |
| Relying PI Checklist (DOCX) | 9/4/24 | This checklist should be reivewed by the PI in order to review the responsibilities in assuming the role of relying PI for a study under single IRB ovesight. A signed copy should be submitted via iRIS with the initial submission packet. |
| FORM | REVISED | DESCRIPTION |
|---|---|---|
| NIH Biospecimen Decision Chart (PDF) | 6/25/19 | Used to Assist the Researcher in Determining Whether the OHR-19 Criteria Apply |
| OHR-5 (DOCX) | 8/12/25 | This form is used when completing a case report request with the Privacy Office. Note: This form is not used in submissions to the IRB within iRIS. |
| Case Report Checklist (PDF) | 8/2023 | This form is a checklist for anyone who is submitting a Case Report of case series . |
| OHR-17 (DOCX) | 11/11/21 | Certification for Use of PHI of Decedents for Research |
| OHR-19 (DOCX) | 1/29/25 | Research Involving Coded or Anonymous Private Information and Biological Specimens. Note: This form is now incorporated into the Non-Human Subject Research (NHSR) application in iRIS. Please submit the NHSR application to obtain documentation that your project does not require IRB review. |
| OHR-29 (DOCX) | 11/11/21 | Review Preparatory to Research Request Form |
| SKCCC Biorepository Request (PDF) | 5/13/26 | A utilization request form submitted to the SKCCC translational research group prior to IRB review. Address all questions to stefany.hinojosa@jefferson.edu. This form does not need to be incldued with your IRB application. |
| Request for Data Transfer & Use Agreement (DOCX) | 01/06/24 | Use to request preparation of a data transfer & use agreement (DTUA) when a study involves sharing of data with or from entities outside of Jefferson and such sharing is not already covered in a research contract. |
| FORM | REVISED | DESCRIPTION |
|---|---|---|
| OHR-25 (DOCX) | 11/1/18 | Device Worksheet |
| OHR-26 (DOCX) | 5/2012 | Research Involving Children |
| OHR-27 (DOCX) | 5/2011 | Research Involving Pregnant Women, Fetuses, and Neonates |
| OHR-28 (DOC) | 5/2011 | In Vitro Diagnostic Device Research |
| OHR-32 (PDF) | 3/2026 | Radiation Research Review Form |
| Description | Version Date |
|---|---|
| Greenphire ClinCard FAQ Pamphlet (PDF) | 02/06/2023. |
| Language for OHR-8 (DOC) | 01/22/2016 |
| ICF Addendum for W-9 Threshold Increase (PDF) | 03/19/2026 |
| Cash Withdrawal With Bank Teller (PDF) | 11/15/2017 |
| Patient ClinCard Receipt Template (PDF) | 02/06/2026 |
| Patient ClinCard Receipt Fillable (PDF) | 03/19/2026 |
| W-9 Form (PDF) | 03/2024 |
| Foreign Tax Form W-8BEN (PDF) | 10/2021 |
If you would like more information about Greenphire Clincard, please visit the JCRI Research Systems resources website or email JCRI@Jefferson.edu.
FAQ Pamphlets
| DESCRIPTION | VERSION DATE |
|---|---|
| Chinese - Simplified (PDF) | 12/2019 |
| Chinese - Traditional (PDF) | 05/2018 |
| Creole (PDF) | 12/2019 |
| French - Canada (PDF) | 12/2019 |
| Korean (PDF) | 07/2019 |
| Portuguese - Brazil (PDF) | 12/2019 |
| Russian (PDF) | 12/2019 |
| Spanish - US (PDF) | 12/2019 |
| Vietnamese (PDF) | 12/2019 |
Patient Receipt Templates
| DESCRIPTION | VERSION DATE |
|---|---|
| Chinese - Simplified (PDF) | 05/24/18 |
| Chinese - Traditional (PDF) | 05/24/18 |
| Korean (PDF) | 05/17/18 |
| FORM | REVISED | DESCRIPTION |
|---|---|---|
| iRIS Access Request for non-Jefferson personnel (DOCX) | 09/20/22 | iRIS Access Request for unaffiliated individuals |
| Signature Form for Study Application for iRIS | 08/24/22 | Form to obtain signatures for Chairs/Supervisors and Business Administrators without access to iRIS |
| OHR-31 (DOCX) | 07/08/15 | Waiver Request for Inclusion/Exclusion Criteria |
| OHR-33 (DOCX) | 11/01/18 | IRB Approved Protocols and External Funding |
| OHR-34 (DOCX) | 03/04/26 | Research Not Requiring IRB Review: A Checklist Note: This form is now incorporated into the Non-Human Subject Research (NHSR) application in iRIS. Please submit the NHSR application to obtain documentation that your project does not require IRB review. |
| OHR-35 (DOCX) | 02/2020 | Checklist for Undergraduate Research Study |
| OHR-36 (DOCX) | 03/06/19 | Quality Improvement vs Human Research Decision Tool Note: This form is now incorporated into the Non-Human Subject Research (NHSR) application in iRIS. Please submit the NHSR application to obtain documentation that your project does not require IRB review. |
| OHR-37 (DOCX) | 05/22/20 | Checklist for International Research |
| OHR-38 (DOCX) | 05/22/20 | Subcontractor Checklist: Safeguarding and Protecting Children |
| Radiology Research Feasibility Assessment | 10/07/16 | Online Form to Be Completed When a Study Needs Radiology Approval Prior to IRB Submission |
| AI Screening Form (DOCX) | 06/18/26 | Screening form to be completed when artifical intelligence is used in a reearch study. |