What is direct access?

Direct access is the right to examine, analyse and verify records that are important to the evaluation of a clinical trial without requiring an intermediary.

What are source records?

Source records are original documents or data (which includes relevant metadata) or certified copies of the original documents or data, irrespective of the media used.

Source records may include participants':

• medical records (including Electronic Medical Records / EMR or Electronic Health Records / EHR)
• laboratory test results
• diagnostic imaging systems and diagnostic test results (e.g., CT / MRI scans and reports)
• prescriptions
• chemotherapy order forms
• Patient Reported Outcomes (PROs)
• questionnaires
• diary cards
• rating scales

Why is direct access to source records required?

Direct access to source records is required for trial-related monitoring and audits by sponsors, reviews by the Institutional Review Boards (IRBs), and Good Clinical Practice (GCP) inspections by Regulatory Authorities to examine, analyse and verify that:

• The rights, safety and well-being of participants are protected;
• The integrity of the trial data is assured; and
• The clinical trial is conducted in compliance with the protocol, and applicable regulations, GCP and standard operating procedures (SOPs).

Who should be granted direct access to source records?

The Principal Investigator (PI) should grant direct access to source records to:

• Sponsor (e.g., Monitors, Auditors);
• IRB (e.g., IRB staff); and
• Domestic (e.g., GCP Inspectors from the Health Sciences Authority) and foreign Regulatory Authorities

Any party with direct access should take reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of participants' identities and their data and sponsor's proprietary information.

It will not be required for the GCP Inspectors to sign a separate Non-Disclosure Agreement (NDA), Confidentiality Disclosure Agreement (CDA) or Letter of Undertaking for direct access.

How can direct access to source records be granted?

Direct access to source records for Monitors, Auditors, IRB staff and GCP Inspectors should be restricted to screened and/or enrolled participants for the trial being evaluated.

• If the source records are available in paper format, the original or certified copies of the source records should be provided to the party requesting for direct access.
• If the source records are available in electronic format (e.g., EMR), full, direct and read-only access via a unique identification method (e.g., username and password) should be provided to the party requesting for direct access.
• The direct access should also include access to audit trails.
• If a computerised system is decommissioned, direct access (with a unique identification method) to the data in a timely manner should still be ensured.
• Please note that access to source records via over-the-shoulder access (e.g., via navigation by the investigator site staff) or provision of printed Electronic Medical Records (EMR) is not synonymous with direct access. The former limits access limits freedom of navigation, whilst the latter limits full access to the source records, as not every source record is printed.

What are the Principal Investigator's responsibilities for direct access?

The Principal Investigator (PI) should:

• Ensure that informed consent materials and informed consent discussion informs the participants or their legal representatives (where applicable) about the persons who will be granted direct access to the participants' source records (e.g., regulatory authorities and sponsor representatives), the extent of such access and the extent to which records identifying the participant will be kept confidential, and that consent is obtained from the participants or their legal representatives for such access.
• Provide direct access to all trial-related records upon request of the Monitor, Auditor, IRB or Regulatory Authority.
• Ensure that the personal data (e.g., NRIC for account creation) of the requesting party is protected.

What are the sponsor's responsibilities for direct access?

The sponsor should:

• Obtain agreement from the investigator / institution and where applicable, service provider, to permit monitoring and audits by sponsors, inspections by regulatory authorities, and reviews by IRB, including providing direct access to source records and facilities of the investigator site and service providers.
• Ensure that direct access is specified in the protocol or documented agreement that the investigator(s)/institution(s) provide direct access to source records for monitoring, audits, IRB review and GCP Inspections.
• Ensure that participants have consented to direct access to source records for monitoring, audits, IRB review and GCP Inspections.