Conducting clinical trials

  7. ​Template forms

​Template forms

This page contains a list of template forms to assist you in conducting clinical trials.

Overview

The following list of template forms have been compiled from best practices noted from Good Clinical Practice Inspections conducted to date.

You may also choose not to use these templates if you have suitable alternatives available.

Disclaimer

These template forms are issued by HSA solely for the purpose of facilitating the conduct of your clinical trial. If necessary, customise these template forms to suit the needs of your clinical trial.

These template forms are provided on an "as is basis" for use at your own risk and without warranties of any kind. To the fullest extent permitted by law, HSA does not warrant and hereby disclaims all express, implied and statutory warranties of any kind to you or any third party whether arising from usage, custom, trade or by operation of law or otherwise, including but not limited to the following:

  1. Any representations or warranties as to the accuracy, correctness, reliability, timeliness, non-infringement, title, merchantability or fitness for any particular purpose of the template forms; and
  2. Any representations or warranties that the template forms will be error-free or that errors will be corrected.

HSA will not be liable to you or any third party for any loss or damage whatsoever including but not limited to direct, indirect, punitive, special or consequential damages, loss of income, revenue or profits, lost or damaged data, or damage to your computer, software, modem, telephone or other property, arising directly or indirectly from either of the following:

  • Accessing or using the template forms
  • Relying on any statements, opinions, representations or information in the template forms
  • Any decision, conduct or the views of any person taken in reliance on the contents of the template forms

It remains the responsibility of the sponsor and investigator to implement and maintain quality assurance and quality control systems to ensure that clinical trials are conducted in compliance with the protocol, standard operating procedures, Good Clinical Practice and applicable regulatory requirements.

HSA will not be in a position to review sponsor and site SOPs. In the event if you have any clarifications on the template forms, please submit an enquiry to HSA_CT@hsa.gov.sg.

References Used

Templates

S/NCategoryTemplate FormPurpose of Template Form
1ProtocolProtocol Signature PageDocument the investigator's agreement to read and comply with the protocol and its amendments.
2ParticipantsParticipant Identification LogTrack the identity of the participants enrolled in the clinical trial.
Participant Screening and Enrollment LogTrack the screening and enrollment of participants for the clinical trial.
Participant Visit Schedule LogTrack the scheduled and actual trial visits of the participants enrolled in the clinical trial to ensure that they comply with the trial visit schedule described in the protocol.
3Investigator Site StaffDelegation LogDocument the persons or parties to whom the Principal Investigator (PI) has delegated trial-related activities.
Training LogDocument the training received by the investigator site staff, in order to ensure they are appropriately qualified to conduct their delegated tasks in accordance with the Delegation Log..
4SubmissionsIRB & HSA Submissions Tracking LogEnsure that the required IRB and HSA approvals are sought prior to the implementation of essential records, where applicable.
5Informed ConsentInformed Consent Tracking LogEnsure that informed consent has been obtained from the participants or their legal representatives prior to trial participation, and that reconsent has been obtained from the participants, where applicable.
6Investigational Product (IP) managementIP Management SOPProvide written instructions on the handling and storage of Investigational Products (IP) used in this clinical trial.
IP Inventory LogDocument the IP inventory at the investigator site, taking into account the quantity of IP received at the investigator site and dispensed to participants.
IP Storage Temperature LogEnsure that the IP is stored as specified by the sponsor and in accordance with applicable regulatory requirement(s).
IP Storage Temperature Excursion ReportDocument any temperature excursions noted during IP shipment or IP storage.
IP Repackaging and Re-labelling FormEnsure that the IPs are manufactured, handled and labelled in a manner that aligns with the treatment assignment and maintains study blinding (where applicable).
IP Transfer Log [NEW]Document the transfer of the IP for the clinical trial.
IP Dispensing and Accountability LogDocument that the IP is used in accordance with the approved protocol.
IP Return / Destruction LogDocument the return / destruction of the IP for the clinical trial.
7Safety ReportingAdverse Event (AE) Tracking Log [NEW]Track the AEs reported for each participant for the clinical trial, as defined in the trial protocol.
Serious Adverse Event (SAE) Tracking LogTrack the occurrence and notification of SAEs reported for the clinical trial, as defined in the trial protocol.
8Deviations and NoncomplianceDeviation and Noncompliance Tracking LogDocument and track deviations and non-compliances for the clinical trial.
9Biological SamplesBiological Samples Handling LogDocument the location of the retained biological samples.
10Essential RecordsSource Records Location List [NEW]Define what is considered to be a source record(s), the methods of data capture and their location prior to starting the trial.
Investigator Site File Contents PageProvide guidance on the essential records to be maintained by the investigator.
Previous Essential records