26.2 Good Documentation, Completeness and Corrections

ACRP CCRA Certified Clinical Research Associate Study Guide 2026 Exam

Track your progress as you read

Finished sections get a check mark.

1 Chapter 1: Exam Format, Eligibility and Registration

1.1 Exam Format, Eligibility and Current References 1.2 Registration, Fees and Candidate Decisions

2 Chapter 2: CRA Responsibilities and Study Planning

2.1 The CRA Role, Data Integrity and Product Oversight 2.2 Official Blueprint and Study Strategy

3 Chapter 3: Protocols, Endpoints and Trial Design

3.1 Protocol Elements and Endpoint Hierarchy 3.2 Endpoint Interpretation and Eligibility Rationale 3.3 Eligibility Verification and Trial Designs

4 Chapter 4: Bias Control, Blinding and Product Information

4.1 Bias, Randomisation and Comparator Controls 4.2 Unblinding and Investigator Brochure Content 4.3 Reference Safety Information and IB Updates

5 Chapter 5: Estimands and Device Instructions

5.1 Estimands and Intercurrent Events 5.2 Device Instructions, Configuration and Training

6 Chapter 6: Ethical Foundations and Independent Oversight

6.1 Ethical Foundations and the 2024 Declaration of Helsinki 6.2 Vulnerability, Voluntariness and Compensation 6.3 IRB/IEC Composition and Independent Review

7 Chapter 7: Ethics Communication and Informed Consent

7.1 Ethics Reporting, Approval Status and Version Control 7.2 Informed Consent Information and Meaningful Choice 7.3 Consent Documentation, Special Circumstances and Updates

8 Chapter 8: Recruitment, Retention and Confidentiality

8.1 Ethical Eligibility, Recruitment and Retention 8.2 Privacy, Confidentiality and Appropriate Access

9 Chapter 9: Safety Definitions and Classification

9.1 Adverse Event Definitions and Actual Life-Threatening Risk 9.2 Seriousness, Severity and Medical Importance 9.3 Causality, Expectedness and Reference Safety Information

10 Chapter 10: Safety Detection, Reporting and Oversight

10.1 Detecting Events, AESIs and Collection Windows 10.2 Expedited Reporting and the Sponsor Awareness Clock 10.3 Immediate Site Reporting and Independent Safety Oversight

11 Chapter 11: Follow-Up, Adherence and Conflicts

11.1 Safety Communications, Reconciliation and Follow-Up 11.2 Adherence, Discontinuation and Participant Choice 11.3 Conflicts of Interest and Prorated Payments

12 Chapter 12: Development Stages and Product Management

12.1 Nonclinical Background and Human Pharmacology 12.2 Exploratory, Confirmatory and Therapeutic-Use Studies 12.3 Product Storage, Labelling and Excursion Response

13 Chapter 13: Accountability, Integrity and Regulatory Status

13.1 Product Accountability and Adherence Calculations 13.2 Potential Fraud, Misconduct and Evidence Preservation 13.3 Submissions, Authorisation Status and Trial Reporting

14 Chapter 14: Current GCP Principles and Delegation

14.1 The Eleven Current GCP Principles 14.2 Proportionality and Investigator Oversight 14.3 Delegation, Qualifications and Task Authority

15 Chapter 15: Oversight, Protocol Control and Amendments

15.1 Clinical Oversight and Immediate-Hazard Changes 15.2 Deviation Classification and Resolution

16 Chapter 16: Implementation and Trial Responsibilities

16.1 Amendment Implementation and Communication 16.2 Sponsor, Investigator and Service-Provider Roles

17 Chapter 17: Quality Planning, Root Causes and CAPA

17.1 Quality Planning and Risk Management 17.2 Root Cause Analysis and CAPA Design 17.3 CAPA Implementation and Effectiveness Verification

18 Chapter 18: Risk Assessment and Monitoring Methods

18.1 Risk Assessment and Centralised Surveillance 18.2 Monitoring Methods and Source Review

19 Chapter 19: Quality Metrics, Plans and Communication

19.1 KRIs, Acceptable Ranges and Trial-Level Quality 19.2 Monitoring Plans, Co-Monitoring and Communication

20 Chapter 20: Site Qualification and Readiness

20.1 Site Qualification and Investigator Capacity 20.2 Recruitment Feasibility and Evidence-Based Site Selection 20.3 Site Readiness and Activity-Specific Release

21 Chapter 21: Initiation, Equipment and Supplies

21.1 Initiation Training and Readiness Walkthroughs 21.2 Equipment, Maintenance and Study Supplies

22 Chapter 22: Samples, Diagnostics and Financial Feasibility

22.1 Specimens, Diagnostic Results and Rater Quality 22.2 Contracts, Budgets and Operational Feasibility

23 Chapter 23: Interim Monitoring and Reporting

23.1 Interim Visit Preparation and Consent Review 23.2 Monitoring Eligibility, Safety and Products 23.3 Investigator Debrief and Monitoring Reports

24 Chapter 24: Essential Records, Audits and Findings

24.1 Essential Records and Site/Sponsor Reconciliation 24.2 Version History, Resolution Evidence and Noncompliance 24.3 Audits, Inspections and Closure Planning

25 Chapter 25: Close-Out, Retention and Destruction

25.1 Close-Out, Archiving and Continuing Obligations 25.2 Retention, Destruction and Long-Term Access

26 Chapter 26: Source Records and Good Documentation

26.1 Source Records and Foundational ALCOA Principles 26.2 Good Documentation, Completeness and Corrections 26.3 Source Access, Certified Copies and Context

27 Chapter 27: Electronic Systems, Metadata and Queries

27.1 EDC Design and Fit-for-Purpose Systems 27.2 Audit Trails, Electronic Outcomes and Device Choice 27.3 Queries, Coding and Supported Clinical Meaning

28 Chapter 28: Dataset Finalisation and Critical Data

28.1 Safety Reconciliation and Dataset Finalisation 28.2 Critical Data, Acquisition Tools and Interim Findings

26.2 Good Documentation, Completeness and Corrections

Key Takeaways Explain This Topic AI

Late entries should distinguish actual entry timing from the known historical event.

Corrections preserve the original entry, attribution and explanation as needed.

Missing information should remain honestly identified rather than replaced by a convenient value.

Last updated: October 2026

Good Documentation, Completeness and Corrections

Record source data contemporaneously with the assessment, intervention or observation. Delaying data entry introduces recall bias, memory lapses, and factual distortion.

Late Entries Protocol: When clinical realities prevent instantaneous charting (e.g., emergency resuscitation or high-volume surgical procedures), any subsequent documentation must be explicitly labeled as a "Late Entry." The author must record: (1) the current calendar date and time the note is written, (2) the known historical event date/time, with uncertainty identified rather than invented precision, and (3) their signature/initials. Back-dating a record (writing yesterday's date to make an entry appear timely) is a severe regulatory non-compliance.

Original (O)

Source data must be captured in the primary recording medium first touched by the observer. Transcribing values from loose scraps of paper, sticky notes, or temporary whiteboards into the official chart—and then discarding the scrap—violates the "Original" requirement. The loose paper was the true original.

Certified True Copies (ICH E6(R3)): When original paper records must be digitized or copied (e.g., off-site scanning or archival conversion), the resulting copy must qualify as a Certified True Copy . Under ICH E6(R3), a certified copy is an exact copy (photocopy, scan, microfiche) that has been verified—via a dated signature or a validated electronic verification process—to have the exact same information, including data describing the context, content, and structure of the original.

Certification Mechanics: The individual verifying the copy may document certification with wording such as: "Certified True Copy of the original record," followed by their signature, printed name, and date of verification. Partial scans missing double-sided pages, cropped margins, or unreadable lab attachments fail true copy standards.

Accurate (A)

Source data must represent a truthful, uncorrupted, and mathematically correct representation of clinical facts. Accuracy implies that data are free from transcription errors, represent plausible physiological ranges, and are supported by diagnostic evidence.

Medical Plausibility: A recorded pulse rate of 18 bpm in an alert outpatient or a markedly abnormal laboratory result without documented clinical review calls data accuracy into question and requires prompt investigation.

Protocol Adherence: The CRA verifies that numerical scores on validated psychometric instruments (such as HAM-D, ADAS-Cog, or RECIST tumor measurements) were calculated accurately using protocol-specified scoring algorithms.

Complete (+)

Source records must account for every assessment, visit, laboratory panel, and diagnostic test mandated by the clinical study protocol.

Documenting Omissions: In clinical research, a blank data field is ambiguous—it could indicate that the assessment was omitted, that the test was negative, or that the result was lost. If a protocol-mandated procedure was not completed (e.g., subject refused blood draw, ECG machine broken), the source document must explicitly state: "Test not done: [clinical reason]," attributed to the appropriate responsible person.

All Pages Accounted For: Multi-page survey instruments, multi-lead ECGs, and multi-sheet lab summaries must be complete without missing intermediary pages.

Consistent (+)

Clinical data across multiple distinct source documents within the same investigative center must demonstrate mutual concordance without contradiction.

Cross-Source Triangulation: If the physician progress note states that the patient experienced "mild nausea lasting two hours post-infusion," but the nursing flowsheet records "severe vomiting and IV ondansetron administration," an internal inconsistency exists that must be queried and reconciled.

Chronological Coherence: Medication stop and event resolution dates can differ legitimately; query an apparent inconsistency rather than assuming the dates must match.

Enduring (+)

Data must be recorded upon physical or digital media engineered to survive without degradation throughout statutory retention periods (as determined by applicable requirements and the sponsor’s retention needs).

Thermal Paper Degradation: A classic CRA monitoring finding involves thermal paper printouts from automated ECG machines, laboratory balance scales, or pharmacy temperature dataloggers. Thermal output may fade; evaluate the medium and preserve a durable readable record.

Mandatory CRA Action: The CRA must instruct site staff to photocopy or scan vulnerable records in a timely way under a suitable verified process, certify the copy as a Certified True Copy, and retain records under the approved copying and retention process in the subject source binder.

Available (+)

Clinical records must be promptly retrievable and accessible for review by authorized personnel—including CRAs, sponsor quality assurance auditors, ethics committee representatives, and regulatory inspectors—throughout the active trial and the statutory post-trial archive period.

Physical & Digital Readiness: Secure or off-site storage can be appropriate if authorised retrieval and readability are maintained. A missing retrieval route or deactivated access that prevents necessary review is a concern to resolve.

Official sources

Checked October 18, 2026: ICH E6(R3), Principles and Annex 1 , ICH E9(R1) .