CIMC cheat sheet

RACI matrix assigns roles: Responsible (does work), Accountable (owns outcome), Consulted (provides input), Informed (kept updated).

Tuckman's stages of team development: Forming, Storming, Norming, Performing, Adjourning.

SMART goals are Specific, Measurable, Achievable, Relevant, Time-bound.

A study team typically includes principal investigator, sub-investigators, study coordinator, monitor, data manager, and sponsor oversight.

Delegation log documents tasks delegated by PI to study staff; must be signed and dated by PI.

Conflict resolution modes: collaborating, compromising, accommodating, competing, avoiding.

Key performance indicators for site performance include enrollment rate, screen failure rate, protocol deviation rate, and query resolution time.

Training records must be maintained for all study staff and updated when protocol amendments occur.

ICH GCP E6(R2) is the international ethical and scientific quality standard for clinical trials.

FDA Form 1572 is the Statement of the Investigator, required for IND studies; must be updated when site information changes.

IND safety reports: 7-day for unexpected fatal or life-threatening suspected adverse reactions; 15-day for other serious unexpected suspected adverse reactions.

EU Clinical Trials Regulation (EU) No 536/2014 requires submission via the Clinical Trials Information System (CTIS).

Informed consent form, protocol, and investigator brochure are essential documents requiring IRB/IEC approval before study start.

Annual reports to FDA for IND studies are due within 60 days of the anniversary of the IND effective date.

Protocol deviations that affect subject safety or data integrity must be reported to the IRB per institutional policy.

Regulatory binders must contain essential documents per ICH GCP E6(R2) Section 8.

Primary endpoint must be pre-specified and directly related to the primary objective.

Inclusion/exclusion criteria define the target population; overly restrictive criteria reduce generalizability and slow enrollment.

Feasibility assessment includes site patient volume, competing trials, staff experience, and equipment availability.

Sample size calculation requires effect size, power (typically 80% or 90%), alpha (typically 0.05), and variability estimate.

Protocol synopsis summarizes objectives, design, eligibility, endpoints, and statistical methods.

Adaptive designs allow pre-planned modifications based on interim analyses; must control type I error.

Risk-based monitoring approach should be defined in the protocol or monitoring plan.

Protocol amendments require IRB/IEC approval before implementation, except to eliminate immediate hazard.

Site initiation visit (SIV) verifies site readiness, training, and investigational product accountability before enrollment.

Essential documents must be collected and filed before site activation; includes FDA 1572, CVs, licenses, and IRB approval.

Site activation checklist typically includes contract execution, budget approval, IRB approval, and IP shipment.

Pre-study qualification visit assesses site feasibility and capability.

Enrollment tracking uses screen failure logs and enrollment logs to monitor site performance.

Site communication plan should define frequency and mode of contact between sponsor/CRO and site.

Investigational product accountability records must document receipt, dispensing, return, and destruction.

Site close-out visit ensures all essential documents are complete and IP reconciled.

100% source data verification (SDV) is not required; risk-based monitoring focuses on critical data and processes.

Monitoring plan should define scope, frequency, and methods (on-site, remote, central).

Query resolution time is a key metric; unresolved queries can delay database lock.

Protocol deviation log must capture date, description, root cause, corrective action, and impact.

Serious breach of GCP or protocol may require site suspension or termination.

Monitoring reports must be provided to sponsor after each visit; follow-up letters document findings and action items.

Key risk indicators (KRIs) include enrollment rate, query rate, deviation rate, and SAE reporting timeliness.

Central monitoring uses statistical algorithms to detect anomalous data patterns across sites.

Case report form (CRF) design should collect only data required by protocol and avoid redundant fields.

Database lock occurs after all queries are resolved and data are clean; prevents further changes.

Intention-to-treat (ITT) analysis includes all randomized subjects; per-protocol analysis includes only compliant subjects.

Missing data handling methods include complete-case analysis, multiple imputation, and last observation carried forward (LOCF).

Statistical analysis plan (SAP) must be finalized before database lock.

Data validation uses edit checks and range checks to identify discrepancies.

Randomization codes must be kept confidential and unblinded only per protocol.

Adverse event coding uses MedDRA; concomitant medications coded with WHO Drug Dictionary.

Serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization, causes disability, or is a congenital anomaly.

SUSAR: Suspected Unexpected Serious Adverse Reaction; must be reported to regulators and IRBs within required timelines.

Sponsor must report serious unexpected suspected adverse reactions to FDA within 15 calendar days; fatal/life-threatening within 7 calendar days.

Investigator must report SAEs to sponsor immediately, typically within 24 hours of awareness.

Causality assessment categories include related, possibly related, unlikely related, and not related.

Pregnancy occurring during study must be reported and followed to outcome.

Safety monitoring plan should include periodic review of aggregate safety data by a data safety monitoring board (DSMB) when appropriate.

MedWatch Form 3500A is used for mandatory reporting of serious adverse events to FDA.

Per-patient budget includes costs for screening, study visits, procedures, and overhead.

Pass-through costs (e.g., IRB fees, central lab) are billed separately from site service fees.

Payment schedules often tie invoicing to milestones such as enrollment, visit completion, and database lock.

Clinical trial agreement (CTA) defines scope, payment terms, indemnification, and publication rights.

Budget negotiation should ensure fair market value and avoid inducement for enrollment.

Financial disclosure by investigators is required for FDA-regulated studies (Form 3454/3455).

Site overhead or institutional fees are typically a percentage of direct costs.

Budget tracking uses actual vs. budgeted expenses to manage variance.

Belmont Report principles: respect for persons, beneficence, and justice.

Informed consent must be obtained before any study-related procedure and documented in writing.

Informed consent form must include purpose, duration, procedures, risks, benefits, alternatives, and contact information.

Vulnerable populations (children, prisoners, pregnant women, cognitively impaired) require additional safeguards.

IRB/IEC must review and approve the protocol, consent form, and recruitment materials.

Assent from minors is required when appropriate, in addition to parental permission.

Consent must be voluntary and free of coercion; subjects may withdraw at any time without penalty.

HIPAA authorization is required for use of protected health information in research, with some exceptions.