CCRC study plan

Map the full CCRC exam content outline into a one-page checklist, listing every task statement under the single JTA domain and marking each as known, shaky, or unknown

Define the coordinator's role boundaries against the principal investigator, sponsor, and IRB, and write a two-sentence distinction for each pair

List the core documents that govern a trial (protocol, investigator's brochure, informed consent form, manual of procedures) and state the purpose of each in one line

Build a personal glossary of 25 foundational terms (adverse event, serious adverse event, protocol deviation, eligibility criteria, source document) with a working definition for each

Sequence the pre-study start-up steps a coordinator owns, from site feasibility through site initiation visit, and note the coordinator action at each step

Draft the questions a coordinator must answer before signing a site on: staff qualifications, competing trials, recruitment pool, and equipment availability

Explain the difference between site feasibility and site qualification, and identify which coordinator tasks belong to each

Practice writing a site initiation visit agenda that names the coordinator's preparation tasks and training records needed

Describe the informed consent process step by step, including who may conduct it, timing relative to any study procedure, and documentation requirements

Identify the elements that must appear in a consent discussion for a vulnerable population and explain how re-consent is triggered

Distinguish informed consent from assent and from authorization for use of protected health information

Analyze three short hypothetical consent scenarios and write the correct coordinator action for each

Outline the coordinator's source documentation duties: what counts as a source, who may record it, and how corrections are made

Explain ALCOA-C principles and apply each element to a specific coordinator task

Describe how to prepare for and support a sponsor monitoring visit, including what to have ready and how to log queries

Practice resolving a set of mock data queries, writing the correction, the source support, and the response

Define adverse event and serious adverse event using the regulatory criteria and classify ten short event descriptions correctly

Map the coordinator's safety reporting timeline from event awareness to sponsor and IRB notification, and state the coordinator's action at each point

Explain causality and severity assessment and why the coordinator documents but does not unilaterally assign them

Describe how protocol deviations are identified, documented, graded, and reported, and distinguish major from minor

Describe investigational product accountability from receipt through return or destruction, naming every record the coordinator maintains

List the storage, handling, and dispensing controls a coordinator verifies and explain what to do when a temperature excursion occurs

Explain how randomization and blinding are protected at the site and what coordinator actions could break them

Summarize the coordinator's role in an audit or inspection, including document retrieval and interview conduct

Consolidate the coordinator's communication duties across sponsor, IRB, investigator, and participant, and draft a template for each audience

Explain essential document maintenance and version control through the life of a study, including what is filed where

Review the ethical and regulatory foundations a coordinator is tested on and connect each to a concrete site practice

Complete a timed 60-question practice set and tag every miss back to a task statement on the week 1 checklist

Re-drill only the task statements still marked shaky or unknown from the week 1 checklist and the week 7 error log

Recite from memory the coordinator actions for consent, safety reporting, and investigational product accountability without notes

Complete a second timed practice set under exam conditions and compare performance against week 7

Write a one-page personal exam-day plan covering timing, question triage, and how to handle unfamiliar scenario items