Source Documentation and CRF

What is Source Documentation?

Source documentation is the medical record of the subject before, during and after the trial.

It is the tool which confirms the eligibility criteria of the subject in the given trial.

It documents the progress of the subject from consenting till the subject completes the study. It records the accountability of the investigational product dispensed, consumed and returned by the subject. It serves as the complete medical record of the subject as the reference to the treating physician at any point of time.

Finally it forms a strong foundation for the data that gets transcribed into a CRF which ultimately gets translated into a clinical study report.

Irrespective of clinical trial, accurate documentation supports the fundamental principle of protecting subject’s rights, safety and well-being.

What is the purpose of Source Documentation?

The most important purpose of source documentation in a clinical trial is to reconstruct the trial as it happened. It should enable an independent observer to reconfirm the data. Documentation should be such that it is able to provide audit trail to permit investigation if and when required.

What is source data?

All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).

What are source documents?

Original documents, data and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, X-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial).

Study Coordinators are responsible to store source data in electronic Case Report Forms (eCRF) or directly in Electronic Data Capture (EDC) system.

Evolution of CRF over the years:

What is Case Report Form?

A Case Report Form (CRF) is an electronic or paper document which is used in a clinical trial to record the protocol and required information about each participant. It enables efficient and complete data collection, processing, analysis and reporting. It is the main tool that Investigators use to collect information from clinical trial participants which is why there needs to be one completed CRF for each participant. 

The Sponsor-Investigator puts together the CRF Completion Guidelines and ensures that the site staff have received training before collecting, entering and reviewing data. 

All users are given a unique username and password to gain access to the CRF and the trial database. The Principal Investigator assigns permissions to each user which includes ‘data entry’ or ‘data view only’. Permission to access the data must be in accordance with the consent given by participants.

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