Clinical Trials Operations (GCP and ICH)
GCP is a documentation discipline
ICH E6 defines GCP as a standard for designing, conducting, recording and reporting trials involving human subjects, and operational questions test who owns what. The sponsor initiates, manages and finances the trial; selects investigators; provides the investigator brochure; ensures monitoring; handles regulatory safety reporting; and owns the trial master file. The investigator conducts the trial at the site, obtains consent, secures IRB/IEC approval, maintains the investigator site file, supervises the team, and is accountable for source data. A CRO acts under a written transfer of obligations, and ultimate accountability stays with the sponsor.
Distinguish monitoring, auditing and inspection: monitoring is ongoing sponsor oversight of the site; auditing is an independent, systematic examination of trial-related activities; inspection is a regulatory authority's review. Source documents anchor everything, and ALCOA principles require records that are attributable, legible, contemporaneous, original and accurate. Delegation must be documented before tasks are performed, and the delegation log must reflect actual practice. Unblinding should be documented with a reason. Investigational product accountability, storage conditions and dispensing records are classic inspection findings.
Trap: the staff member who clearly performed a task but is absent from the delegation log, or the deviation described in a meeting but never documented.
Rule of thumb: if it was not documented, it did not happen. Worked example: a coordinator phones a participant with a visit reminder. If the call is not logged, no contemporaneous record of the contact exists, and "it was only a courtesy call" does not satisfy source documentation requirements.