CCRA study plan

Map the CRA role across the trial lifecycle and write a one-page summary of pre-study, initiation, routine monitoring, and close-out responsibilities

Define the core monitoring vocabulary (source data verification, source document, CRF, protocol deviation, ALCOA-C) in your own words with a site-based example for each

Build a personal glossary spreadsheet of 40 CRA terms with a definition and a real-world scenario column

Draft the anatomy of a monitoring visit report: purpose, required sections, timelines for submission, and follow-up letter

Walk through the informed consent process end to end and list the documentation checks a CRA performs at each step

Compare source documents against CRF entries in a practice scenario and identify transcription discrepancies

Explain how protocol deviations are classified, documented, escalated, and reported, with worked examples of major versus minor

Describe the purpose and required elements of a site initiation visit checklist

Outline the essential documents a site must hold before, during, and after a trial, and state who maintains each

Explain ICH E6 GCP principles and how they map to CRA monitoring activities

Describe the roles of IRB/IEC and regulatory authority submissions and what a CRA verifies about approvals and renewals

Identify the elements required in an investigator brochure and protocol that a CRA checks for site readiness

Explain the informed consent regulatory requirements including voluntariness, capacity, re-consent, and vulnerable populations

Describe safety reporting pathways: SAE definitions, reporting timelines to sponsor and IRB, and the CRA's role in follow-up

Distinguish the CRA's responsibilities from sponsor and site responsibilities in unblinding and safety unblinding scenarios

Summarize privacy and data protection obligations that affect source document access and data transfer

Draft a site communication plan covering routine contact cadence, escalation paths, and documentation of contacts

Practice writing a follow-up letter that converts monitoring findings into clear, prioritized action items with due dates

Explain how to conduct an opening and closing meeting with site staff and what to confirm in each

Describe strategies for managing difficult site conversations such as persistent non-compliance or slow enrollment

Explain root cause analysis for recurring site issues and how corrective and preventive action plans are written and tracked

Describe escalation of unresolved site issues to sponsor management and the documentation trail required

Outline how audit and inspection readiness is assessed at a site and what records a CRA prepares

Identify common findings in GCP inspections and the monitoring practices that prevent them

Complete timed mixed-domain practice sets and log every missed question by domain and error type

Review weak areas by rewriting the underlying rule or process in your own words

Rehearse explaining a monitoring finding, its regulatory basis, and the corrective action in under two minutes

Recheck your glossary and reference sheets against what practice sets revealed as gaps

Take two full-length timed practice exams under test conditions and compare scores by domain

Target the two lowest-scoring domains with focused review of your error log and reference sheets

Recite key timelines, definitions, and document requirements from memory without notes

Finalize a one-page pre-exam summary sheet you can review in the final 24 hours