Principal Investigator Compliance Assessment (PICA)- For Greater Than Minimal Risk Research Continuing Review

The Office of Clinical Research and IRB are collaborating to design a self-monitoring tool for research teams within the Perelman School of Medicine (PSOM) to be able to use to conduct a self assessment at the time of continuing review submission to the IRB. The goal of this new Self Assessment Program is to assist investigators and their research staff in ensuring that clinical research is being conducted according to the applicable regulations and University policies.

The IRB Continuing Review form refers to the PICA in relation to site monitoring. Study teams conducting greater than minimal risk biomedical research who do not have a sponsor appointed study monitor for quality control of site activities are expected to be familiar with the PICA. This form should be completed annually and filed in the regulatory binder for the study. Submission of the completed PICA form to the IRB is not required (It will be returned to you). Study teams should instead inform the IRB of any issues and corrective actions identified via this process.

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*Please note that this form is published by OCR. Any questions about this form should be directed to that office.

Community Partner Training

The Community Partner Training is an online human research protections training program for community based research projects.  The curriculum can be completed in approximately two hours and can be used by community partners as a substitute for CITI training.  The Community Partner Training includes real-world examples and content tailored to the unique roles of community partners engaged in research.  Research coordinators and faculty can log-in to the program and create projects, track their community partners’ progress, and download a certificate of completion to submit to the IRB.

 

Visit http://cptraining.med.upenn.edu to learn more.

 

For questions, contact Sarah Green (shgreen@upenn.edu), Victoria Worthen (vworthen@upenn.edu) or Jill McDonald (jillrmcdonald@gmail.com).

 

Electronic Data (PHI) Protection / Storage/ Transmission Plan Requirements

All new submissions received after August 1, 2016 that involve the use of directly-identifiable electronic protected health information will be required to include data confidentiality plans that align with the requirements outlined in the documents below. A description of your data confidentiality plan and how it aligns with these new requirements should be included in response to the “Subject Confidentiality” question in HS-ERA.

Click here to download the guidance document outlining requirements for electronic data protection for research involving the use of directly-identifiable protected health information

Click here to download the companion guide that outlines key features of IRB-approved mechanisms for data storage and transmission that comply with the new requirements.

Clinical Trials Registration

All US drug or device clinical trials must be registered on ClinicalTrials.gov in accordance with the FDA Amendment Act of 2007. Please note:  The Office of Regulatory Affairs no longer handles ClinicalTrials.gov requests.

The Compliance group in the Office of Clinical Research (OCR) now manages all ClinicalTrial.gov requests.  Please contact them at ocrctgov@exchange.upenn.edu to request assistance.

Certificates of Confidentiality (CoC)

Certificates of Confidentiality allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding. See the NIH Certificate Kiosk for additional information.

Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality (CoC)

Monday, September 11, 2017

To increase the protection of privacy of research participants, as of October 1, 2017, NIH funded researchers who are who are collecting identifiable, sensitive information as part of their NIH funded research will automatically be issued a CoC as part of the term and condition of their award. There is no need for them to apply for a CoC. Compliance with the privacy protections afforded by the CoC is also a term and condition of award. All research that was commenced or ongoing on or after December 13, 2016 and is within the scope of this policy is issued a Certificate through this policy.  See NOT-OD-17-109 

For further assistance, please contact: Dave Heagerty

Conflicts of Interest (COI)

Pleasee see the Office of the Vice Provost for Research, COI Policies, and the COI submission system.

For further assistance, please contact: Dave Heagerty , Tracy Ziolek or the Conflicts of Interest Standing Committee.

Data & Safety Monitoring (DSM)

Download guidance.

For further assistance, please contact: Tracy Ziolek or visit the Office of Clinical Research for additional information.

NIH Genome Wide Association Study (GWAS) Registry

Any request to submit data into the NIH Genome-Wide Association Studies repository must include certification that the submission has been approved by the responsible Institutional Official. At Penn the IRB serves that function and this guidance document details (i) how to submit requests for GWAS certification to the IRB, (ii) how the IRB will consider these requests and (iii) how studies can be drafted to ensure that IRB Certification can be granted.

Download guidance.

For additional assistance, please contact: Patrick Stanko or Heather Emery.

Scientific and Scholarly Validity

The IRB is one component of the Human Research Protections Program (HRPP) at the University of Pennsylvania . Please review the attached guidance which explains how the Penn HRPP works together to ensure all research is well designed to meet its aims and will result in meaningful data that contributes to generalizable knowledge, while also protecting human subjects. 

Click here to download guidance

ICH Good Clinical Practice (ICH/GCP) Compliance

Good Clinical Practice (GCP) is an international stardard provided by the International Conference for Harmonisation (ICH) for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials or studies.

Click here to view the letter for Sponsors describing Penn IRBs' position on compliance with ICH GCP.

Download guidance.

For additional assistance, please contact: Any Senior Administrator listed on the directory