Is it essential to identify location of source data?
Girish Deodhar
The primary purpose of source data verification is for monitors, auditors and inspectors to check compliance of conduct of the clinical trial to ICH GCP guidelines, regulations and guidelines, and clinical trial protocol. Source data could be available in variety of source documents e.g., medical records, laboratory reports, patient diaries, nurses' notes, drug dispensing logs, electrocardiogram printouts, X-ray images, etc. The regulatory inspectors have noted that data are recorded in multiple locations at a site. Review of source documents at all relevant locations is critical to ensuring quality and reconstructing the clinical trial conduct. Hence, the regulatory inspectors expect that a detailed identification list of all source documents and data is available to facilitate monitoring, audit, and inspections.
This list should be prepared by the site and should be signed and dated by the principal investigator or by a person whom the principal investigator has assigned this task. The list should be filed in the investigator's trial master file. As the location of source data could vary from one investigator site to another, the list should be site specific. Also, the list of source data should be sufficiently detailed and appropriately labelled e.g., 'patient record – dispensing and administration.
How do you record patient eligibility in source data?
Dr Sudha Doshi
Regulatory inspectors expect that details of how the patient satisfy eligibility criteria are recorded in source documents and source data. GCP inspections have revealed significant gaps in documentation of eligibility criteria. Often, documentation of review by the investigator of all criteria prior to inclusion is missing.
The enrolment criteria may originate from diverse sources e.g., clinical examination, medical history, lab tests, imaging etc. The sponsor should carefully consider where each source data originate from, with reference to a specific visit of patient. A qualified physician who is an investigator or a sub-investigator should assess each individual eligibility criteria and document the final decision to enrol the patient in the clinical trial. The sponsor should agree with the investigator how adherence to the individual inclusion and exclusion criteria is documented.
What are the expectations of electronic trial master file (eTMF) from audit or inspection perspective?
Veena Viswanathan
During regulatory inspection or audit, limited time is available for review of all relevant documents. So, the inspectors would need:
• eTMF system adequately replicating the functionalities of a paper based TMF system and providing for suitable document identification, search, prompt retrieval and marking for future reference/copying.
• System with reliable and fast response time
• Prompt access to eTMFs - live and archived on servers
• Overall TMF index in to assist finding documents in the TMF
• Read-only access to all documents in the eTMF, without any restriction
• Self-evident naming convention that readily identifies what each folder/file/document contains
• Ability to open more than one document at a time to enable comparison
• Ability to provide access to the same type of document across all studies/product or across sponsors
Access to the audit trial of the eTMF systems and the ability to obtain exports of the audit trial.
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