Drug Evaluation Committee 2023-06 Scope of ALCOA
Related classification: Other
Date of first publication：August 2023
Question
I feel that ALCOA support for the preparation and revision of source documents has taken root in Japan. According to the GCP notice, source documents are records necessary to reproduce and evaluate the factual course of a clinical trial, such as medical records, examination notes, and administration records of investigational drugs, etc., pertaining to a subject. The GCP Notice of Operation defines source documents as records necessary to reproduce and evaluate the factual course of a clinical trial, such as medical records, examination notes, and administration records of investigational drugs.
Looking at "records necessary to reproduce and evaluate the factual course of the clinical trial" alone, it could be read as all materials generated in the clinical trial.
For example, if a worksheet is used to create an investigational drug administration record (which is the basis for the CRF), is an ALCOA also required to revise the investigational drug administration chart (which is not the basis for the CRF)? Since most of the documents available on the Internet and other sources cite the subject's medical data as an example, we would like to know your opinion on whether administrative documents around the clinical trial and documents that are not the basis for CRFs or physician judgment fall under records necessary for reproduction and evaluation of the factual process.
Pharmaceutical Association's Opinion
As GCP Article 2 Guidance 6 defines "source documents" as "documents, data, and records that provide information on the factual progress of a clinical trial and that serve as the basis for case reports and other documents, data, and records. Source data" included in source documents is defined in Guidance 18 (12) of the same article as "all information recorded in the original records and certified copies of the original records concerning clinical findings, observations, and other activities in the clinical trial, which are necessary for reproduction and evaluation of the factual course of the clinical trial," and is defined in GCP Article 41, Paragraph 1, Item 4. The GCP Article 41.1.4 also defines that the original data must satisfy the ALCOA. In addition, Article 21.1.9 (11) of the GCP defines that monitors "shall ensure that all clinical trial-related records, including source documents, that are accurate, complete, and up to date are prepared and maintained. This means that all source documents (including source data) must be prepared in accordance with ALCOA.
If the information on the worksheet is original data, it is a record that reproduces the process of administration and a record that reproduces the receipts and disbursements of the clinical trial, respectively, and therefore, it is necessary to prepare documents based on ALCOA. ALCOA is required to prepare the documents based on the ALCOA.