Good Documentation Practices

Clinical Trials

Source documents are essential documents that are required for Good Clinical Practice. It is the first place where data are recorded for a clinical trial. High-quality source documentation is crucial for ensuring data integrity, and enabling accurate investigation and validation at any time. Across the globe, clinical professionals emphasize the importance of maintaining strong documentation practices to uphold the reliability of research. Below are examples of source documents for a clinical study:

• Case Report Forms
• Electronic Case Report Forms
• Clinical Charts
• Subject Diaries
• Evaluation Checklists
• Patient Medical Records
• Laboratory Results/ medical results such as MRI, ECG, etc.

To ensure high-quality and reliable clinical trial data, certain documentation standards must be followed. ALCOA+ is an acronym used to identify documentation requirements for ensuring the data are attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available.

Does your Source Documentation Meet ALCOA+ Guidelines?

Attributable: It should be clear who completed the source document at a site. Is the person who performed the study task easily identifiable? Documents should be signed and dated by all appropriate people such as the PI, Sub-Investigator/Co-Investigator, Coordinator or study participant. Signatures should be easily identifiable with the study Delegation of Authority log maintained by the site.

Legible: It is important that handwritten data can be easily read and free of errors. However, if an error is made, the original data must not be obscured.  Corrections are made by drawing a single line through that error. The person making the correction should write their initials, date and the correct data near the original error. Legible data are essential for the integrity of the overall study.

Contemporaneous: Data collected for a study should be documented at the time a task is performed. A date field must always be completed with the current date even if the information was collected previously. Backdating in clinical research can cause concern because the writer is depending on their memory and wrong information could potentially be entered. Remember, the source document is the first place data were recorded so it is important to always keep the original source. Forms from a patient visit should flow, tell a sequential story and leave no room for questions.

Original: The primary data source or a certified copy must be maintained. A copy of a copy is not an acceptable form of data.

Accurate: It is important for the site to write a truthful and thorough representation of facts for the study. Documentation should reflect exactly what occurred, ensuring that the data accurately represent the conduct of the trial.

Complete: All source documents must be thoroughly completed, with no blank fields or missing entries. Blank sections on a CRF can create ambiguity and may lead the monitor- or an auditor- to infer that a study procedure was either not performed or not documented appropriately. Blank fields can be marked through with a single line, initials, and date to reduce confusion.

Consistent: Is your site consistently capturing data in the same way each time a study related task is performed? Maintaining uniformity in how procedures are followed and data are recorded are essential throughout the trial. This includes adhering to the same practices, providing uniformity, and minimizing variations in how data are entered onto CRFs.

Enduring: Following the departure of study personnel, it is essential to confirm that their associated documentation remains accessible. These records should be properly archived and readily available for review, as they may need to be referenced or audited for years after study completion to ensure data integrity and regulatory compliance.

Available: Are documents and records readily accessible for audits or inspections? Sites should have clear filing systems and document control procedures to guarantee that all required records can be promptly retrieved when requested by monitors, sponsors, or regulatory authorities.

In conclusion, the ALCOA+ principle serves as a foundational guideline for ensuring data integrity and compliance in clinical trials. By adhering to these standards, organizations can maintain trustworthy records that support transparency, accountability, and traceability. It also safeguards data quality and reinforces a culture of integrity and excellence across all operational processes.

MED offers a variety of clinical trial services and is a full-service CRO. We have over 40 years of experience designing and executing clinical trials, ranging from early feasibility studies to multinational, controlled pivotal trials to post-market registries.

Contact us today to start your project discussion 855.463.1633 | askmed@medinstitute.com | medinstitute.com.