You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
Your site is weeks past study initiation and all the candidates that you expected to be screening for the study have not materialized. Would trial-related advertising or recruitment materials enhance your sites enrollment efforts?
Topics: 21 CFR Part 56, IRB, Clinical Trial Enrollment
Your site is weeks past study initiation and all the candidates that you expected to be screening for the study have not materialized. Would trial-related advertising or recruitment materials enhance your sites' enrollment efforts?
Topics: 21 CFR Part 56, FDA, Clinical Research
In clinical research, the purpose of an Institution Review Board (IRB) is to review and approve research studies involving human subjects. Its purpose first and foremost is to protect patients by ensuring the rights, safety, and well-being of potential research subjects. 21 CFR part 56 contains general standards for the composition, operation, and responsibility of an IRB that reviews clinical investigations regulated by the FDA.
Topics: Medical Device CRO, IRB Oversight, 21 CFR Part 56