CRA (OPS) study plan

Summarize the historical cases (Nuremberg, Tuskegee, thalidomide, Belmont) and state the ethical principle each produced.

Map each ICH GCP E6(R2) principle to the corresponding 21 CFR 50, 56, or 312 citation in a crosswalk table.

Differentiate the approval, amendment, and continuing-review responsibilities of the IRB, the sponsor, and the investigator.

List the required elements of informed consent under 21 CFR 50.25 and identify five common consent deficiencies.

Define when a legally authorized representative is required and which populations are treated as vulnerable.

Sequence the activities of pre-study, initiation, interim, and close-out visits and list the documentation required at each.

Perform source data verification on three mock subject files, flagging every transcription discrepancy between source and CRF.

Apply the ALCOA-C criteria to classify ten seeded source-documentation errors.

Draft a post-visit follow-up letter for a mock visit containing three findings ranked by severity.

Build a site qualification checklist covering personnel, facilities, equipment, and recruitment potential.

Evaluate investigator CVs and a draft Form FDA 1572 against protocol and training requirements.

Calculate a site's enrollment feasibility using historical screen-failure and retention rates.

Identify the essential documents that must exist at a site before a qualification visit.

Assemble the essential-document sections of the trial master file required by the end of site initiation.

Draft an initiation visit agenda and a site training log covering protocol, IP handling, and AE reporting.

Reconcile delegation-of-authority log entries against training records and the Form FDA 1572.

Classify twelve mock events as SAE, serious non-AE, or non-serious AE using ICH E2A definitions.

Assign expedited reporting timelines (7 vs 15 days) by applying expectedness, causality, and severity, and draft one MedWatch 3500A narrative.

Trace an investigational product shipment from receipt through dispensing, reconciliation, and return or destruction.

Compute accountability discrepancies in a mock drug log and state the required escalation path and timeline.

Outline storage, temperature-excursion handling, and blinding-emergency procedures for a double-blind trial.

Identify the documentation required to support IP destruction and site-level unblinding.

Write queries for ten seeded data errors, matching query type to the nature of the discrepancy.

Distinguish SDV-driven, edit-check, and medical-review queries and state their expected resolution timelines.

Describe medical coding and the prerequisites for database lock.

List close-out visit activities and separate documents retained at the site from those retained by the sponsor.

State the record retention and access requirements under 21 CFR 312.62 and ICH GCP.

Re-map the ten highest-yield regulations to the specific monitoring activities each one governs.

Classify twenty scenario items as major or minor protocol deviations and justify each call.

Re-test Domain 1 and Domain 4 question sets and re-teach every subdomain that fell below 80%.

Rehearse the escalation and documentation steps for a suspected serious breach of GCP or of the protocol.

Complete two full-length timed mock exams under exam conditions without notes.

Review every missed item and write a one-line rule capturing the underlying concept.

Recite from memory the key numeric thresholds: 7- and 15-day expedited reporting, 30-day safety report, and records-retention periods.

Re-read the personal weak-area log and confirm each entry is closed.