ACRP-CP study plan

Map the ICH E6(R2) GCP principles and the responsibilities of sponsor, investigator, IRB/IEC, and monitor onto a single one-page diagram

Differentiate Phase I through Phase IV trial objectives, typical sample sizes, and design features in a side-by-side comparison table

Explain randomization methods, blinding levels, control-arm selection, and endpoint definitions by writing a short protocol synopsis of your own

List the protocol, investigator's brochure, and essential documents that must exist before a site can be activated

Compare the Belmont Report principles, the Declaration of Helsinki, and the U.S. Common Rule, noting where they converge and where they diverge

Outline the required elements of informed consent under ICH E6 and describe how consent is documented for vulnerable populations

Classify adverse events, serious adverse events, SUSARs, protocol deviations, and unanticipated problems using a decision tree you construct

Describe IRB/IEC composition, quorum, quorum loss, and continuing review requirements

Sequence the drug development lifecycle from discovery through Phase IV and post-marketing commitments

Summarize the FDA and EMA submission pathways, including IND, NDA, BLA, MAA, and expedited designations such as orphan, fast track, and breakthrough

Distinguish the roles of ICH efficacy and safety guidelines in assembling a regulatory submission package

Explain how a regulatory inspection is prepared for and which documents inspectors typically request

Trace trial conduct from pre-study visit through close-out, listing the essential documents required at each stage

Apply ICH E6 requirements for source documentation, CRF completion, and record retention periods

Devise corrective and preventive actions for three common GCP deviations such as consent errors, missed visits, and unreported serious adverse events

Write a monitoring follow-up letter that states findings, root cause, and the agreed corrective action plan

Draft a site feasibility and start-up checklist covering budget negotiation, contracts, and essential document collection

Build a sample per-patient budget and distinguish pass-through costs from site overhead and institutional charges

Plan recruitment, screening, and retention tactics with quantified enrollment and dropout targets

Describe delegation of authority, training documentation, and investigator oversight expectations for delegated tasks

Differentiate EDC, ePRO, and CTMS systems and describe how data flows from entry to the clinical database

Apply ALCOA+ and data-integrity principles to a deliberately messy source-document scenario and correct every defect

Explain the query generation and resolution workflow and list the prerequisites for database lock

Identify where MedDRA and WHO Drug dictionaries are applied when coding adverse events and concomitant medications

Practice delivering and receiving constructive feedback in a simulated coordinator-investigator conflict and note what you would change

Outline decision-making and escalation paths for a disagreement between investigator and sponsor over protocol deviation handling

Identify sources of implicit bias in trial teams and name two concrete strategies for inclusive communication

Draft and rehearse a five-minute briefing on a trial delay written for a non-scientific stakeholder audience

Sit one full-length timed mock examination under exam-day conditions with no notes or interruptions

Re-sort every missed item from the mock by domain and identify the two weakest domains

Re-study only the two weakest domains using condensed notes and a targeted 20-item drill on each

Re-take a shortened 25-item set on the two weakest domains and confirm the score improves by at least 15 percentage points