Protocol Development

Penn Risk Management Guidance, Tool, and Training Deck

The Office of Clinical has developed the attached tool and cover sheet, in collaboration and consultation with experts in navigating risk management in an environment similar to Penn (not pharma). The cover sheet allows you to streamline and customize the documentation of risks as appropriate for the study. Existing studies do not need 2-3 risks documented if a risk assessment or quality plan has been previously documented. If nothing exists, we recommend documenting risks as indicated in the instructions. We do strongly recommend the tool be used for all new study teams and new programs.

A training deck has been included for additional information.

For questions on this information and potential walk through/ training sessions, please contact the Office of Clinical Research

More on RBQM:
Per section 5.0 of ICH GCP E6 R2, and as adopted by FDA, sponsors and sponsor-investigators conducting federally regulated research at Penn under an IND/IDE, are required to follow GCP and ensure a system is in place to manage quality throughout all stages of the trial process. Recent revisions to ICH E8, and regulators also refer to this as a Quality by Design (QbD) approach.  As part of a QbD approach, focus should be given to trial activities considered essential to ensuring human subject protection and the reliability of trial results. These activities or study parameters considered most critical are also known as “Critical to Quality (CTQs) factors or attributes.  Note that GCP adherence is also required for greater than minimal risk clinical research receiving NIH funding.

Risk Management Guidance Attachments

Risk Management Training Cover Sheet
Risk Based Quality Management Training 
Risk Management Tool Excel 

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Study Start Up and Management Tools and Best Practices

  • Cohort Identification and Feasibility (click on this and expansion is on the page with the text below )

In the early trial design stage it may be beneficial to take a look at exactly how many available subjects within Penn Medicine there are for a trial. This can be helpful information to include in a grant proposal or when planning a recruitment strategy. It may also be necessary information to provide to an external sponsor during the site selection process. Below is a quick snap shot and some more details about some of the resource available to support this.

 

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Study Registration in PennCTMS

All Penn studies in fitting with SOP 400 should be registered in the PennCTMS. Registration can take place well in advance of IRB submission during the planning stage of the study. If the study does not move forward the record can be closed.

If the study does continue, then the record can be linked to PennChart and patient status information will be shared between the two systems.

For more information on PennCTMS

[Recruitment Strategy Development and Options

IRB Submission Process 

Contracting/ ORS

Study Record Creation in PennChart — See document notes]

Electronic Documentation Tools

Study Registration in PennCTMS

All Penn studies in fitting with SOP 400 should be registered in the PennCTMS. Registration can take place well in advance of IRB submission during the planning stage of the study. If the study does not move forward the record can be closed.

If the study does continue, then the record can be linked to PennChart and patient status information will be shared between the two systems.

For more information on PennCTMS

Recruitment Strategy Development and Options (this will take you to the Penn Manual of Clinical Research)

Click here for Recruitment Resources Available @ Penn Medicine

IRB Submission Process 

Contracting/ ORS

Study Record Creation in PennChart 

Electronic Trial Documentation Tools

For more information on data classification and sensitivity please review the following policy, PSOM IS Data Classification Policy

For more information on data handling requirement, sensitivity and security, please review the following PSOM Data Handling Policy