About the Patient-Oriented Research Certification Program

Introduction
Certification Levels
Program Credits
  References/Resources
Frequently Asked Questions
Download the POR Policy (revised 12/2/03)

Introduction

The School of Medicine has initiated a Patient Oriented Research Certification Program (Certification Program) which is mandatory for all School of Medicine Faculty, Clinical Care Associate Physicians, Physicians at affiliated Hospitals, and research staff working with those physicians who conduct Patient Oriented Research (clinical research trials). The Certification Program requires training on Clinical Trial regulations including in-depth coverage of the Food and Drug Administration (FDA) and Office of Human Research Protections (OHRP) regulations that apply to Clinical Trials. The program covers requirements for the use of human subjects in research including coverage of Good Clinical Practice (GCP) guidelines, Institutional Review Board (IRB) Review, Informed Consent, Conflict of Interest, and Penn policies and procedures that apply to the conduct of Clinical Research. Each investigator will be required to demonstrate an understanding of the regulations by passing a test developed from the materials covered during the training.

The Certification Program will be required of all faculty, Clinical Care Associate (CCA) physicians and physicians serving as Principal Investigator (PI) at affiliated hospitals and their research staff that interact with research subjects when conducting Clinical trials. Research staff includes all study team members (Sub-investigators, Coordinators) and anyone involved with the conduct of the study. Once certification is obtained, it will remain active for 3 years, at which point re-certification will be required. The re-certification will consist of completion of new and updated modules and a comprehensive test. However, there will be a continuing obligation to receive and review periodic updates in order to maintain certification Periodic updates will be used to inform PIs and research staff of changes in federal regulations or Penn policies and procedures and will be given on an as-needed basis. Failure to review Certification Program updates in a timely manner will result in the revocation of certification.

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Certification Levels

The POR certification program consists of a series of web-based training modules, each of which are followed by an online quiz.  Upon review of the content and achieving a passing score on each quiz, the learner will be provided with a link which will produce a Certificate according to the level of certification completed.

The program consists of two levels of certification:

Expedited Review Certification:
Expedited review certification is the lower level of certification and consists of the following modules:

    1. Historical Perspectives on Human Subject Protection
    2. IRB and Overview of Federal Regulations
    3. Conflicts of Interest

Expedited Review Certification is designed for Investigators and research staff whose Human Research is limited to the performance of research that is eligible for expedited or exempted review by the IRB (such as routine blood draws or survey research – see IRB listing for definition of exempted review – please refer to footnotes). The training program for this level of certification will cover the same materials as Fulll Review Certification with the exception of Good Clinical Practices.

It is important to note that the PI is responsible for determining whether he or she may need to submit a protocol which will require full review by Penn’s IRB necessitating Full Review Certification. If subsequent to obtaining Expedited Review Certification, it is determined that the Investigator’s protocol will require full review, it will be the Investigator’s responsibility to obtain Full Review Certification before Penn’s IRB will grant the Investigator an approved protocol number. It is also the PIs responsibility to ensure that his research team receive the appropriate level of certification following the same guidelines as the PI.

Full Review Certification:
The Full Review Certification is designed for Principal Investigators and research staff who conduct any type of clinical research. Investigators will be required to complete all training modules and pass each associated exam to be granted this level of certification.  It is recommended that all PI's obtain Full Review Certification unless you are certain that all your protocols will qualify for Expedited Review as determined by the UPENN IRB.

Full Review Certification requires the completion of all of the following modules:

    1. Historical Perspectives on Human Subject Protection
    2. IRB and Overview of Federal Regulations
    3. Conflicts of Interest
    4. Introduction to Good Clinical Practices
    5. FDA Regulations in Clinical Research (IND/IDE)
    6. Informed Consent
    7. Adverse Events
    8. Data and Safety Monitoring
    9. FDA Audits

For general inquiries into the POR certification program, please feel free to email Michelle Ziegmann, Office of Human Research, mziegman@mail.med.upenn.edu or phone 215-746-7400.

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Frequently Asked Questions

Who has to take the POR training?
This program is mandatory for all School of Medicine Faculty, Clinical Care Associate Physicians, Physicians at affiliated Hospitals, and research staff working with those physicians that conduct Patient Oriented Research (clinical research trials).

Researchers conducting clinical studies with federal funding are also required to take human subjects research training. This POR program can fulfill this requirement.

UPenn's IRB requires that researchers conducting clinical trials complete patient-oriented research training. This POR program can fulfill this requirement.

An investigator working on a clinical study is required by federal regulations (OHRP and FDA) to ensure that his/her research staff are properly trained. Research staff includes all study team members (Sub-investigators, Coordinators) and anyone involved with the conduct of the study. The POR program was designed with this requirement in mind, and as noted above, is required by the School of Medicine for research staff working with those physicians that conduct clinical research trials.
I already took the NIH mandatory training - do I have to take this also?
Yes.  The POR Certification Program is more comprehensive and includes specific issues of Penn's Policies and Procedures that are not covered in the online NIH training. However, the POR Certification Program will meet NIH's mandatory training requirement, so if you take only the POR program, you will meet both Penn and NIH's training requirements.
How long is the certification good for?
3 years.  During that time, you are required to view any new or updated information that becomes available as part of the POR certification program.
I took the POR previously. How can I get a copy of my certificate?
Go to the POR Certificate request page and complete the form. POR certifications completed pror to December 3, 2003, are valid until December 4, 2004.
I don't have a PennKey, but need to take the POR training?
Faculty, staff, and students of the University of Pennsylvania; employees of the University of Pennsylvania Health System (UPHS) are all eligible to obtain PennKey's, and should do so following the procedures for obtaining and registering a PIN at www.upenn.edu/computing/pennkey/help/pin.html.

For non-Penn employees who are working on UPenn clinical studies and are required to complete the training, a PennKey and password for the purposes of the POR program can be obtained.  Call 573-INFO for more information.

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