CCRC cheat sheet

Feasibility assessment evaluates protocol complexity against site resources: competing trials, eligible patient volume, staff certifications, equipment, and pharmacy capability.

Site selection visit confirms investigator qualifications (CV, licensure, GCP training), adequate facilities, and ability to enroll the target population within the recruitment window.

Essential documents must be collected and filed before site activation: signed protocol, investigator agreement (Form FDA 1572 for IND studies), financial disclosure, IRB approval, and lab certifications.

Form FDA 1572 lists the investigator, subinvestigators, facility, and IRB; any change to site staff or facility requires a revised 1572 before the person performs study tasks.

Clinical trial agreement and budget negotiation must align payment terms with actual per-patient costs; the budget should itemize start-up, per-visit, and pass-through costs.

IRB approval must be obtained before any study-related procedure; the coordinator confirms the approval date, expiration date, and approved consent version match the activated documents.

Site initiation visit (SIV) trains staff on protocol procedures, source documentation, IP handling, and safety reporting; delegation of duties log is finalized at or before SIV.

Activation requires a complete regulatory binder and documented training; enrollment cannot begin until sponsor, IRB, and site approvals are all in place.

Recruitment planning should specify referral sources, screening logs, and prescreening criteria so that screen failure reasons can be tracked and reported.

Informed consent is a process, not a signature: the coordinator must ensure the participant understands purpose, risks, benefits, alternatives, and voluntariness before signing.

Consent must be obtained before any study-specific procedure, including screening tests performed solely for eligibility determination.

The participant (or legally authorized representative) must personally date and sign the IRB-approved consent form; the person obtaining consent also signs and dates.

Any new risk information or protocol amendment affecting participants requires IRB review and re-consent of currently enrolled participants when the change may affect willingness to continue.

Vulnerable populations (children, prisoners, pregnant women, cognitively impaired, economically disadvantaged) require additional safeguards and, where applicable, assent plus LAR permission.

Assent from minors is documented separately when required; the child's dissent should be respected unless the intervention offers direct benefit unavailable otherwise.

Consent documentation belongs in the participant's file and the regulatory binder; the coordinator verifies the correct version and IRB approval dates on each form.

HIPAA authorization or a waiver must be in place before protected health information is used for screening or research purposes.

Non-English-speaking participants require a short form plus interpreter per institutional policy, with documentation of the oral presentation in the participant's preferred language.

Eligibility must be verified against every inclusion and exclusion criterion using source documents dated before the first dose or study procedure.

Delegation of duties log must list each task and the qualified staff member authorized to perform it; tasks cannot be delegated to untrained or non-listed personnel.

Source documents must be attributable, legible, contemporaneous, original, accurate, and complete (ALCOA); corrections use a single line, initials, date, and reason, never obliteration.

Protocol deviations are documented, classified by severity, reported to the sponsor per timeline, and assessed for impact on participant safety and data integrity.

Investigational product accountability requires receipt, dispensing, and return records reconciled at each monitoring visit; temperature excursions are documented and reported.

Randomization procedures must follow the protocol and IVRS/IWRS instructions; unblinding is documented with the reason and reported to the sponsor.

Concomitant medications, adverse events, and medical history are captured in source and CRF with consistent terminology across both records.

The coordinator maintains the investigator site file and ensures current versions of protocol, IB, and consent forms are in use.

Adverse event: any untoward medical occurrence in a participant administered a study product, whether or not causally related to the product.

Serious adverse event meets one of: death, life-threatening, inpatient hospitalization or prolongation, persistent or significant disability, congenital anomaly, or important medical event requiring intervention.

Seriousness is a medical outcome determination; severity (mild, moderate, severe) is a separate grading and does not by itself make an event serious.

SUSAR (suspected unexpected serious adverse reaction) requires expedited reporting to the sponsor, typically within 24 hours of site awareness, with follow-up within protocol-defined timelines.

Expectedness is judged against the investigator brochure or package insert; an event not listed at the observed specificity or severity is unexpected.

Causality assessment (related, possibly related, unrelated) considers temporal relationship, biologic plausibility, dechallenge/rechallenge, and alternative explanations.

AE documentation includes start and stop dates, severity grade, relationship, action taken, treatment given, and outcome; ongoing events are followed to resolution or stabilization.

Pregnancy occurring during study participation is reported per protocol and followed to outcome; exposure of a partner may also require reporting.

CRFs must be completed from source documents; the source should support every data point entered, and corrections follow ALCOA and audit-trail requirements.

Electronic source and EDC systems must have validated audit trails, access controls, and electronic signature compliance (21 CFR Part 11).

Queries are answered with corrected data plus a documented rationale; the coordinator does not delete original entries.

Source-to-CRF reconciliation is performed before monitoring visits to catch transcription errors and missing visits or assessments.

Window compliance: visit dates and assessments are checked against protocol-defined windows; out-of-window visits are documented as deviations.

Data entry timelines are set by the sponsor; late entry is tracked, and database lock requires resolution of all queries and outstanding issues.

Records retention follows the applicable regulation and site policy; the coordinator confirms the retention period and storage conditions with the sponsor.

Monitoring visits (prestudy, initiation, interim, close-out) verify protocol compliance, source-to-CRF accuracy, IP accountability, and regulatory document currency.

The coordinator prepares for monitoring by assembling source documents, CRFs, regulatory binder, IP records, and a list of open issues before the visit.

Monitoring reports and follow-up letters contain action items with due dates; the coordinator tracks and documents resolution.

Sponsor audits and regulatory inspections may be announced or unannounced; the coordinator verifies credentials and notifies the sponsor immediately upon contact.

Inspection readiness requires a complete, organized regulatory binder, documented training, and source records that support all reported data.

Findings are classified (e.g., critical, major, minor) and require a written corrective and preventive action (CAPA) plan with effectiveness checks.

The coordinator does not destroy or alter records after an audit or inspection notice; retention obligations continue.

IP storage must meet protocol-specified temperature and humidity ranges; temperature logs are reviewed and excursions documented and reported to the sponsor.

Accountability records include date, quantity, lot/serial number, participant ID, and dispenser for every receipt, dispense, return, and destruction.

Blinded IP must be handled so that the blind is not broken; packaging, labels, and emergency unblinding procedures are reviewed with pharmacy.

Biological specimens require documented collection time, processing within protocol-defined windows, labeling with protocol-required identifiers, and storage at specified temperatures.

Shipping requires temperature-controlled packaging, chain-of-custody documentation, and confirmation of receipt at the central lab.

Expired or compromised IP is quarantined and dispositioned per sponsor instruction; it must not be dispensed to participants.

The coordinator is the primary liaison among investigator, sponsor/CRO, IRB, participants, and ancillary departments; communications are documented and dated.

Conflicts of interest must be disclosed per institutional and sponsor policy, including financial interests of the investigator and immediate family.

Confidentiality obligations cover participant identifiers, protocol content, and sponsor data; PHI is shared only per authorization or waiver.

Research misconduct (falsification, fabrication, plagiarism) must be reported through institutional channels; retaliation against good-faith reporters is prohibited.

The coordinator maintains competence through documented GCP training, protocol-specific training, and role-relevant continuing education.

Participant communication respects privacy, literacy level, and language preference; scheduling and reminders support retention without coercion.

Escalation of safety or compliance concerns follows the site's chain of command and, where applicable, the sponsor's medical monitor within defined timelines.

Good Clinical Practice (ICH E6) sets standards for trial design, conduct, recording, and reporting; FDA regulations at 21 CFR Parts 50, 56, 312, and 812 implement corresponding US requirements.

21 CFR Part 50 governs informed consent; Part 56 governs IRB operations; Part 312 covers IND requirements; Part 11 covers electronic records and signatures.

The investigator is responsible for conducting the trial per the signed protocol, obtaining IRB approval, supervising delegated staff, and reporting to the sponsor and IRB.

Essential documents demonstrate compliance before, during, and after the trial; they are filed in the investigator site file and retained per regulation and agreement.

IRB continuing review must occur at least annually or at the interval set by the IRB; approval lapses stop enrollment and new procedures.

Protocol amendments require IRB approval before implementation, except when necessary to eliminate apparent immediate hazard to participants.

The Common Rule (45 CFR 46) applies to federally funded human subjects research and defines additional protections for pregnant women, prisoners, and children.

Closeout activities include final IP reconciliation and return/destruction, resolution of all queries, final monitoring visit, and notification of the IRB.

The coordinator confirms that all CRFs, source documents, and regulatory documents are complete and filed before the site is closed.

Participants are informed of study completion, transition options, and any post-trial access per protocol and institutional policy.

Records retention periods begin at study closeout; the coordinator documents the storage location and custodian and confirms destruction authorization requirements.

Final financial reconciliation confirms payments received match the executed budget and that outstanding invoices are resolved.

The closeout letter from the sponsor documents site closure; the coordinator files it with the regulatory binder and archives study records accordingly.