Clinical Research Operations

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How to Verify Human Research Protection Program (HRPP) Training

Purpose: To identify the process for verify HRPP training. 

Spreadsheets

• The OHSRP database is still not accurately reflecting the appropriate training, so there is a spreadsheet located on the shared folder “CCR_Protocols”, subfolder “Central Regulatory File documents”.  This spreadsheet is maintained by Liz Ness while others will have read access only.
• The document has 4 tabs (i.e., specific spreadsheets) labeled:
• NCI Medical, Lab, PSO Staff
• NCI Research Nurses
• NCI PA and NP Staff
• Non-NCI Staff
• Each spreadsheet is formatted the same way with the 3 Human Subjects Protection course options listed (CITI Biomedical 101, NIH CRT Course, CC Bioethics: Ethical and Regulatory Aspects of Clinical Research) followed by the 2 GCP options (CITI GCP for either PI or non-PI and NIAID GCP full course). The date taken is noted in black while the expiration date is noted in red.
• Though most of the data management staff is not listed on the face sheet and are not KRPs per current definition, they have all taken both HSP and GCP training.  Harris will maintain the spreadsheet for this and send to Liz Ness to provide a copy in the “Central Regulatory File documents” folder. Document is labeled “Harris SOP 25 HRPP Training Records”. 

What to verify

• Requirement for ALL FDA regulated studies (i.e., any study with a drug or device regardless of whether there is an IND or IDE):
• Need 1 of the 3 HSP courses

AND

• Need 1 of the 2 GCP courses
• Requirement for Behavioral studies:
• Need to take NIH CRT

AND

• Need to take CITI Behavioral Research Training module

What to do if an individual is missing the required training, or has expired training

• Email Elizabeth (Liz Ness)  (NIH/NCI) with the protocol # and the individuals who need training and which type of training (e.g., HSP or GCP or both)
• Liz a will then contact those individuals and track until the training is completed.
• The Protocol Specialists or others do not need to hold up the process; submit to IRB simply noting those individuals that have not yet met the required training at the time of submission.

What will the IRB do if the action is ready for "approval"?

• IRB Administrators can contact Liz Ness to confirm that there is an individual(s) who is still not compliant prior to sending response notice. This way training needs can become part of a stipulation.