Good Documentation in Clinical Trials
WHAT IS GOOD DOCUMENTATION IN CLINICAL TRIALS?
The medical record of the subject before, after, and during the clinical trial is a Source Document.
Characteristics of Source document:
It helps to confirm whether the individual is eligible for a clinical trial or not.
It documents the progress of the subject from consenting till the completion of the given clinical study.
It helps to record how much investigational product is dispensed, used, and returned by the subject.
At any point of the treatment, the source document is a complete medical record of the subject as a reference.
Finally, it forms well-built data. Then it is transcribed to CRF that translates into a clinical study report.
The source document is the one that supports the fundamental principles which are necessary for the protection of subjects’ rights, safety, and well-being. ( Chitra Bargaje., 2019)
ALCOA-C:
ALCOA-C covers all the main aspects of a source document that include some crucial definitions and documentations., first introduced by the U.S. FDA.
The reason why it got implemented in medical practices; is to ensure confidentiality, credibility, accuracy, and validation. ALCOA-C is the abbreviation of some crucial terms in clinical trials that are as follow,
Attributable
Legible
Contemporaneous
Original
Accurate
Enduring
Available and accessible
Complete
Consistent
Credible
Corroborated
Types of a Source Document:
There are two types of Source Documentation:
Electronic
Paper
Electronic record means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.
Paper Source Documents can be:
Handwritten data on the pre-printed forms have been prepared in advance.
Handwritten records.
In both cases, the source documents are only the records, either handwritten or printed out, with the original handwritten Investigator's signature.
The most common type of Source Documentation (SD) is official medical documentation used in medical institutions regularly:
Medical History
Outpatient Medical Chart
Various Logs / Hospital Charts
Examples of Source Document in Clinical Trial:
Participant’s medical reports
Phone encounters or notes
Report Participants diaries
Specific research worksheets
Clinical Data Management:
The process of collecting, cleaning, and management of subject’s data following regulatory standards is known as clinical data management (CDM).
Main Objectives of CDM:
To provide high-quality data.
To keep the number of errors and missing data as low as possible.
Try to get maximum data for analysis.
The electronic information obtained from the CDM must comply with the Code of Federal Regulation (CRF), 21 CRF Part 11. CRF operates the existing records in an electronic format that we created, modified, stored, archived, retrieved, or transferred. ( binny et al., 2012)
Case Report Form:
CRF is the first step in the translation of protocol-specific activities into the data being generated. It should be concise, user friendly, and self-explanatory. (binny et al., 2012)
References: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3121265/ - Good documentation practice in clinical research https://conductscience.com/portfolio/alcoa-c/ - ALCOA-C https://www.appliedclinicaltrialsonline.com/view/targeting-source-document-verification - Targeting Source Document Verification https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3326906/ - Data management in clinical research: An overview https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4170533/ - Basics of case report form designing in clinical research https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3857788/ - Remote Source Document Verification in Two National Clinical Trials Networks: A Pilot Study https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4386950/ - Impact of source data verification on data quality in clinical trials: an empirical post hoc analysis of three phase 3 randomized clinical trials