Division of Clinical Research

Office of the Vice President and Innovation

Category results for: IRB

Replies to Inquiries to FDA on Good Clinical Practice

GCP inquiries submitted by the public to the FDA’s Good Clinical Practice Program’s gcp.questions@fda.hhs.gov e-mail account are now available online. FDA on GCP Link: https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/replies-inquiries-fda-good-clinical-practice Visit this FDA page to search through years of answers to GCP related questions on: Adverse Events Inquiries Computer Questions Device Study Inquiries FDA Forms 1571 and 1572 Financial Disclosure Inquiries Foreign […]

Oct. 9 & Oct. 11: Crucial Conversations with the IRB Part II (CReSS Workshop)

Crucial Conversations with the IRB, Part II: “Oops we did it again” Unanticipated Problems, Non-compliance Register for only one of the following two sessions: Wednesday, Oct. 9, from 9 – 10:30 am; MMEC 12‐101/102 Friday, Oct. 11, from 2:30 – 4 pm; MMEC 12‐101/102 The VCU IRB will continue their conversation with research teams in […]

Follow this blog