SOP for Case Report Forms and Source Documents

Purpose

To describe the procedures related to the completion of electronic and paper based Case Report Forms (CRF), and maintenance of Source Documents.

Scope

This SOP applies to all relevant employees including, but not limited to, visiting health professionals, contractors, consultants and volunteers who propose to undertake, administrate, review and/or govern human research involving patients/participants, facilities and or staff. All study personal involved in the clinical study must operate within their scope of practice.

Procedure

1. Completion of Case Report Forms

Where electronic medical records (EMR) are used, a validation system is required with an inbuilt correction and audit trail feature. In the case where there is no inbuilt validated audit trail, printed records of the changes and corrections (e.g. data queries) must be retained.
The Investigator must:

• Ensure the accuracy, completeness, legibility, (including any changes or corrections) and timeliness of Source Data and data recording adheres to the Protocol, monitoring plan requirements and also the Supervision Plan.

• Ensure that any party delegated to perform data entry or signing for data completeness is recorded on the Delegation Log and is trained to perform those trial related duties and functions.
• Ensure that changes to the paper Source Document do not obscure the original entry, are traceable (signed and dated) and explained (i.e. an audit trail should be maintained).

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2. Source Documents

The Investigator must:

• Maintain adequate Source Documents and trial records including all key observations on each of the trial participants.
• Store all trial related documents in a Study Master File/Satellite Site Study File as required by the applicable regulatory requirement, Sponsor and Protocol and take measures to prevent accidental or premature destruction of these documents.
• Ensure, for both paper and electronic documents, all changes, corrections and amendments are tracked, and version dates and numbers, are updated to reflect the changed data and to maintain the integrity of the data. An explanation of the changes is noted in a record of change.
• Ensure all staff are aware that, upon request, direct access to all trial related records is given to the monitor, auditor, HREC, RGO or regulatory authority, to enable Source Data verification, Sponsor audits or regulatory inspection. Direct access is stipulated in the CTRA and outlined to the participant via the PICF.
• Ensure that for telehealth consultations, the call is documented in the participant’s health and medical record at each site as documented in the Supervision Plan, which will detail where the original and certified copies are stored. The written record will include a brief summary of the Protocol number, consultation; follow up instructions and that the visit was conducted via telehealth.
• For paper records, ensure that the agreed approach to Source Documents in the Supervision Plan is followed. This could include requiring a certified copy of any key Essential Documentation generated at the Satellite Site to be sent to the Primary Site for filing in the SMF e.g. SAE reports, to allow remote monitoring by the Sponsor and for auditing and inspection purposes. These can be sent via email or post.

• Where EMR are in use, access to the patient’s/participant’s trial related information must be limited to authorised users only. The Investigator must ensure appropriate controls are in place to allow access to the patient’s/participant’s EMR for the purpose of monitoring the study. Authorised users should include CRAs, auditors and regulatory inspectors, subject to those users meeting local access requirements.
• Where there is not a locally accepted practice to limit access in the EMR to limited patients/participants, other measures must be put in place to ensure the patient’s/participant’s privacy and confidentiality are respected e.g. print the trial related information, sign as a certified copy and place in a paper record for access by Sponsor, regulatory inspectors and auditors etc.

For teletrials, providing access to the Satellite Site EMR from the Primary Site (for PI oversight and study monitoring) is to be encouraged in order to increase the efficiency of study conduct under the Teletrial Model.

Annexure

Nil

Revision History

Nil

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