Per ICH GCP guideline E6 section 5.1 source data is identified as “all information in original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.” This is the first recording of subject-related information. According to 21 CFR 312.62(b), and investigator is required to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual. Source documents must be complete, accurate, and valid. The regulatory authorities consider source documents to be the basis for al trial data and the adjudication of the outcome of events. The purpose of source documents/patient record binder:
- To document the existence of the participant and substantiate integrity of trial data collected.
- To include original documents related to the trial, medical treatment, history of participant, and participant’s condition while on-study or in follow-up. To provide an auditable link in the chain from the study database back to the original source (visit worksheet).
- To collect data for transfer to CRFs and then to the study database.
- To instruct study coordinators and other site personnel on what data to collect and information necessary to answer data queries.
These can be electronic media, original documents or certified copies. The following Source Document Binder Table of Contents is adopted from Partners Healthcare.
| Tab | Documents | Reference |
|---|---|---|
| Informed Consent | Written informed consent form to document that consent is:
Subject Bill of Rights |
OHRP Informed Consent Guidance Information; ICH GCP E6 Section, 4.8 |
| Records | Includes but not limited to hospital, clinic and office records, progress notes, medical history, subject diaries, subject questionnaires unless accessible via EMR | ICH GCP E6 Section 1.5.1, 1.5.2, 8.3.13 |
| Inclusion/Exclusion Checklist | Documentation of subject eligibility to be part of the study | |
| Correspondence | Notes to file, memos, correspondence, documentation of phone or email contact (all subject-related) | |
| Outside reports | Laboratory, X-ray, CT, ECG, etc. | |
| Con Meds, AEs, SAEs | Forms used to collect and document adverse events, concomitant medications, serious adverse events, etc. |