Clinical Research Operations

M2P2s #26-40 

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 #28: I made an error when entering information on a paper form, now what? (REVISED 02/2022)
M2P2 #29: Where did the Cooperative Groups go? (REVISED 02/2022)
M2P2 #30: Why does the FDA inspect IRBs and what do they review? (REVISED 02/2022)
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 #32: What is a Corrective and Preventative Actions (CAPA) Plan?  (REVISED 01/2023)
M2P2 #33: What should I do if I find incorrect or missing information on ClinicalTrials.gov (CT.gov) or NIH Clinical Research Studies? RETIRED 2/2022: Refer to M2P2 #11
M2P2 #34: My patient has had labs drawn outside of the CC. What do I need to do as the research nurse besides ensuring that we get the results and they are scanned into CRIS? (REVISED 02/2022)
M2P2 #35: How does the protocol information get onto the CCR Clinical Trials website?  (REVISED 06/2023)
M2P2 #36: Did you know that you can use the ATV system to obtain a Clinical Center (CC) medical record number (MRN)?  RETIRED 01/2023; Refer to CCR SOP ADCR-13: Clinical Center External Location Registration
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 #40: What does it mean to close a study with the IRB? (REVISED 06/2023)