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

  • 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.
  • The Completed PICA should be sent to the Office of Clinical Research at
    psom-ocrcompliance@pobox.upenn.edu or fax it to (215) 614-0378
  • Do not submit the completed PICA to the IRB via HSERA.

Click Here to Download PICA Form

*Please note that this form is published by The Penn Office of Clinical Research (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. Additionally, the Penn Medicine Privacy office and the PSOM Office of Clinical Research have released guidance in 2020 pertaining to use of Email during the conduct of research and minimizing PHI in Email. Please download the attachment to review all guidance and requirements.

 

Click Here to download Guidance and Requirements for Penn Investigators: Protection of Electronic Data and Protected Health Information

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 or the Conflicts of Interest Standing Committee.

Data & Safety Monitoring (DSM)

Download guidance.

For further assistance, please contact: Jessica Yoos 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