List of M2P2s (updated April 2024)
By Number
M2P2 #61: Where can I find Patient Education materials to teach my patient? (REVISED 01/2022)
M2P2 #62: What does it mean for a research participant to be lost to follow-up? (REVIEWED 01/2022)
M2P2 #63: When is it appropriate to enroll the participant onto protocol 01C0129? (REVIEWED 01/2022)
M2P2 #64: When is it appropriate to enroll the participant onto protocol 04C0165? (REVIEWED 01/2022)
M2P2 #65: How do we interact with the Protocol Services Section (PSS) to register a protocol with clinicaltrials.gov? (REVISED 12/2023)
M2P2 #66: Is there anything special that needs to be done when conducting remote consenting? (REVISED 04/2024)
Guidelines for Adobe Signature
M2P2 #67: What is Serious Adverse Event (SAE) reconciliation? (REVISED 09/2022)
M2P2 #68: I know what a Curriculum Vitae (CV) is, but are there any particulars that I need to know related to CCR requirements? (REVISED 01/2024)
M2P2 #69: What is iMedConsent™? (REVISED 04/2024)
M2P2 #70: What is an Expanded Access Use IND/IDE (also called “Single Patient” or “Compassionate Use”)? (REVISED 07/2023)
M2P2 #71: What is Embedded Agreement Information in PRES? (REVISED 06/2023)
M2P2 #72: What do I need to know about ThinkAndor®? (REVISED 03/2024)
M2P2 #73: What needs to be done for a monitoring/audit visit and who is responsible? (05/2023)
M2P2 #74: What should you do if you have a protocol modification/amendment that impacts one of CCR’s databases? (06/2023)
M2P2 #75: What services are available to help with participant recruitment? (REVISED 04/2024)
M2P2 #76: Who should be notified when a primary completion date (PCD) is met for one of my clinical trials? (REVISED 12/2023)
M2P2 #77: What is a Good Cause Extension (GCE) for reporting results in ClinicalTrials.gov? (REVISED 12/2023)
M2P2 #78: Is it mandatory to redact certain information from a protocol and/or consent for results reporting to ClinicalTrials.gov? (10/2023)
M2P2 #79: What is compensation for research participants? (04/2024)
M2P2 #80: Single Patient Planned Modification (deviation): when and how do I request it from the NIH IRB (05/2024)
Additional Practice Pearls/Tips
PET Scan information (Molecular Imaging Clinic vs. Research Pet Department)