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Question Of The Week:
Where does the Sponsor Company (or CRO) responsibility end when it comes to reporting Serious Adverse Events (SAEs) to Institutional Review Boards (IRB) / Independent Ethics Committees (IEC)?
PREVIOUS QUESTIONS OF THE WEEK:
Question:
Can a Clinical Research Associate (CRA) from CRO or Sponsor write on Case Report Forms (CRF) consequently making changes to CRF data?
Question:
Are clinical investigators required to disclose during the informed consent process that they or their sites are being compesated (paid) for their work in the study?
What does ICH-GCP say on this issue?
