Clinical Research Operations

M2P2 by Topic

Informed Consent
Reportable Events: Sponsor/SAEs and IRB/CR
Documentation and Data Management
Clinicaltrials.gov Reporting 

Informed Consent

M2P2 #24: You learn that your patient doesn’t speak English and you don’t have ANY protocol consent in the patient’s preferred language for healthcare.  What do you do?  Part 1: Determine if Informed Consent (IC) document needs to be translated ASAP & secure interpreter and witness.  (REVISED 08/2024) 
M2P2 #25: You learn that your patient doesn’t speak English and you don’t have ANY protocol consent in the patient’s preferred language for healthcare.   What do you do?  Part 2: Consent Discussion and Documentation  (REVISED 08/2024)  
M2P2 #26: You learn that your patient doesn’t speak English BUT you have an IRB-approved protocol consent  in the patient’s native language (i.e., the full English version translated). How does the consenting process differ when not using the short-form consenting process? (REVISED 08/2024)
M2P2 #27:  If consenting is an ongoing process, what does re-consenting mean?(REVISED 08/2024)
M2P2 #31: What should you do if you notice that there is something missing on the signed informed consent document - paper version?(REVISED 08/2024)
M2P2 #48:  A patient that is blind wants to enroll in a study. How do I enroll someone that cannot read the informed consent document?  (includes information about patients that cannot sign the document)  (links updated 08/2024)
M2P2 #66: Is there anything special that needs to be done when conducting remote consenting? (REVISED 08/2024)
                     Guidelines for Adobe Signature
M2P2 #69: What is iMedConsent™? (REVISED 04/2024)
M2P2 #71:  What is Embedded Agreement Information in PRES? (12/2022)

CCR Frequently Asked Questions on Informed Consent

IRBO FAQs: General and Short Form Consent Processes

Reportable Events: Sponsor/SAEs and IRB/CR

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 #8:  When do I submit a Reportable New Information (RNI) form to the IRB and what happens after the submission?  (REVISED  05/30/2023)
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 #12: You submitted a SAE/AESI to the sponsor, what else needs to happen with the event information? (REVISED 02/2022)
M2P2 #17: What information needs to be reported to the IRB at the time of continuing review (CR)?   (REVISED 02/2023)
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 #42: What is an unexpected adverse event (AE) and how is it be reported to the IRB? (REVISED  06/2023)   
M2P2 #50: What are the expedited IRB reporting requirements for “events” that happen during research?  (REVISED 02/2023)
M2P2 #67:  What is Serious Adverse Event (SAE) reconciliation? (Developed 03/2022)

Documentation and Data Management

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 #14: What is off-treatment versus off-study? (REVISED 01/2022)
M2P2 #28: I made an error when entering information on a paper form, now what? (REVISED 02/2022)
M2P2 #37: You learn that one of your study patients, who is not an inpatient at NIH,  has died. (REVISED 01/2023)
M2P2 #38: What are baseline symptoms and how do I capture them? (REVISED 02/2022)
M2P2 #39: What does it mean to take a patient/participant off-study? (REVISED 01/2022)
M2P2 #62: What does it mean for a research participant to be lost to follow-up?  (REVIEWED 01/2022)

 ClinicalTrial.gov Reporting

M2P2 #41:What is the primary completion date (PCD) and the anticipated completion date (ACD)? Why are these dates important?  (REVISED  01/2023)
M2P2 #76: Who should be notified when a primary completion date (PCD) is met for one of my clinical trials? (07/2023)
M2P2 #77: What is a Good Cause Extension (GCE) for reporting results in ClinicalTrials.gov? (09/2023)
M2P2 #78: Is it mandatory to redact certain information from a protocol and/or consent for results reporting to ClinicalTrials.gov? (10/2023)