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M2P2s #1-25

M2P2 #1: What is the impact on C3D when your protocol has the following optional language (or something similar)? (REVISED 12/2021)
M2P2 #2: What is Good Documentation Practice? (REVISED 12/2021)
M2P2 #3: What information should be included in the narrative summary when reporting an AE to the IRB, or IND/IDE sponsor? (REVISED 01/2023)
M2P2 #4:
What does building “wiggle room” into your protocol procedure time points really mean? (REVIEWED 12/2021)
M2P2 #5: Why should a Nurse have a Curriculum Vitae (CV)? (REVIEWED 12/2021)
M2P2 #6: How can I stay current with regulations, guidances, and other news from OHRP and the FDA?  (REVISED 12/2021)
M2P2 #7: Why do I get so many different emails about required training and how do I keep up with them? (REVISED 12/2021)
M2P2 #8: When do I submit a Reportable New Information (RNI) form to the IRB and what happens after the submission?  (REVISED  01/2023)
M2P2 #9: Since the printed pocket version of CTCAE v.4 is not available, how can I have CTCAE at my fingertips? RETIRED 2/2022
M2P2 #10: How do I submit a MAJOR protocol deviation to the IRB and what do I include in the submission?  (REVISED  01/2023)
M2P2 #11: What should I do if I find incorrect or missing information on 01/2023)
M2P2 #12: You submitted a SAE/AESI to the sponsor, what else needs to happen with the event information? (REVISED 02/2022)
M2P2 #13: What are the responsibilities of the research team when CCR is the coordinating center for a multi-site clinical trial?  (REVISED  01/2023)
M2P2 #14: What is off-treatment versus off-study? (REVISED 01/2022)
M2P2 #15: How do I create, modify, or delete a protocol order set in CRIS? (REVISED 02/2022)
M2P2 #16: When are credentials verified and what do I need to do to maintain my privileges? (REVISED 12/2021)
M2P2 #17: What adverse events SAEs and AEs) need to be reported to the IRB at the time of continuing review (CR) and what format needs to be used?  January 2023 under revision 
M2P2 #18: Why should the Research Nurse be added as a sub-investigator on the FDA Form 1572? (REVISED 02/2022)
M2P2 #19: What is the Safety Monitoring Committee (SMC) and what are my responsibilities as a research nurse?  January 2023 under revision 
M2P2 #20: Documentation of protocol-specific training and the impact for the Research Nurse RETIRED 01/2023, see CCR SOP PM-5 Research Protocol Training Requirements and PM-9 Research Team Amendment Training
M2P2 #21: Who can write an order for IND agents (i.e., drugs & biologics)? (REVISED 02/2022)
M2P2 #22: How to handle Personally Identifiable Information (PII) in a report submitted to the IRB or IND/IDE sponsor? (REVISED 02/2022)
M2P2 #23: What should the Research Coordinator do if there is an ineligible subject who was enrolled on a clinical research study? (REVISED 01/2023)
M2P2 #24: You learn that your patient doesn’t speak English and you don’t have an IRB-approved protocol consent in the patient’s native language. What do you do? Part 1:  Ensuring RB Approval, Obtaining Short Form & Securing Interpreter (REVISED 01/2023) 
M2P2 #25:You learn that your patient doesn’t speak English and you don’t have an IRB-approved protocol consent in the patient’s native language. What do you do? Part 2: Consent Discussion and Documentation  (REVISED 06/2022)  

Last updated by Grady, Deborah (NIH/NCI) [E] on Jan 23, 2023