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This application is a service of the Singapore Government.

Health Sciences Authority

Template Forms

Background

The background for developing this guidance and template forms draws from our experience with conducting GCP Inspections of clinical trials, in which Investigator-initiated clinical trials lack sufficient guidance on the required format of several essential documents in order to ensure compliance with applicable regulations, guidelines and standard operating procedures.

The following list of template forms have been compiled from best practices noted from GCP Inspections conducted to date. It is not mandatory to use these forms if you have suitable alternatives available. Otherwise, you may choose to customise these templates for your clinical trial. We welcome your valuable feedback in improving the design and content of these templates.

DISCLAIMER

These template forms are issued by HSA solely for the purpose of facilitating the conduct of your clinical trial. If necessary, customize 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:

(i) 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

(ii) 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 (i) accessing or using the template forms or (ii) relying on any statements, opinions, representations or information in the template forms or (iii) 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, GCP and applicable regulatory requirements.

 


 

 

Investigational Product (IP) Templates

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Template Form Description
IP Management SOP

This SOP template could be used to provide written instructions to guide the site staff on the management of IP at site. It includes instructions to ensure proper receipt, storage, repackaging (if applicable), dispensing, accountability, return and destruction of the IP.

Useful tips:

  • Roles and responsibilities of the blinded and unblinded study teams should be clearly segregated.
  • Site staff should be delegated on the Signature Sheet.

Applicable References:

  • GCP 5.14.3
IP Inventory Log (Without individual kit number)

This template could be used to document the inventory of the IP at the site, taking into consideration the amount of IP received at site and dispensed to subjects.

Useful tips:

  • Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet.
  • Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
  • Check the physical inventory against the IP Inventory Log on a regular basis.
  • The IP Inventory Log should not be completed electronically, unless the inventory is managed by a validated electronic system.

Applicable References:

  • GCP 4.6.3
IP Inventory Log (With individual kit number)

This template could be used to document the inventory of treatment kits at the site, taking into consideration the treatment kits received at site and dispensed to subjects.

Useful tips:

  • Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet.
  • Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
  • Check the physical inventory against the IP Inventory Log on a regular basis.
  • The IP Inventory Log should not be maintained electronically, unless the inventory is completed by a validated electronic system.

Applicable References:

  • GCP 4.6.3
IP Inventory Log (With IP repackaging done at site)

This template could be used at sites where IP repackaging is done to blind the study treatment. It should be used by the unblinded study team to document the inventory of the bulk IP received from sponsor, repacked and transferred to the blinded team.

Useful tips:

  • Site staff involved in IP repackaging should be part of an unblinded study team.
  • Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet.
  • Separate IP Inventory Logs should be maintained for each IP.
  • The IP Inventory Log should be filed in the Pharmacy Binder, where access is secure and limited to the unblinded study team in order to maintain the study blind.
  • Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
  • Check the physical inventory against the IP Inventory Log on a regular basis.
  • The IP Inventory Log should not be completed electronically, unless the inventory is managed by a validated electronic system.
  • All correspondences concerning IP Management that may potentially unblind the study should be limited to the unblinded study team.

Applicable References:

  • GCP 4.6.3

IP Dispensing and Accountability Log Template

 

(With individual kit numbers)


(Without individual kit numbers)

 

This template could be used to document the accountability of the IP received at the site, dispensed to subjects and returned to site. It serves to ensure that the IP has been used according to the protocol.

Useful tips:

  • Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet.
  • Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
  • Check the physical inventory against the IP Inventory Log on a regular basis.
  • The IP Dispensing and Accountability Log should not be completed electronically, unless the inventory is managed by a validated electronic system.

Applicable References:

  • GCP 4.6.3, 4.6.5
IP Dispensing and Accountability Log Template (With IP repackaging done at site)

This template could be used at sites where IP repackaging is done to blind the study treatment. It should be used by the blinded team to document the accountability of the repackaged IP received from unblinded study team; dispensed to subjects; returned to site by subjects; and returned to unblinded study team. This template serves to ensure that the IP have been used according to the protocol.

Useful tips:

  • Site staff involved in IP repackaging should be part of an unblinded study team.
  • Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet.
  • Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
  • Check the physical inventory against the IP Inventory Log on a regular basis.
  • The IP Dispensing and Accountability Log should not be completed electronically, unless the inventory is managed by a validated electronic system.

Applicable References:

  • GCP 4.6.3, 4.6.5
IP Repackaging and Relabelling Form Template

This template could be used at sites where IP repackaging is done to blind the study treatment. It should be used by the unblinded team to document the IP repackaging and relabelling process, and serves to ensure that the process is conducted in accordance to GMP guidelines.

Useful tips:

  • Site staff involved in IP repackaging should be part of an unblinded study team.
  • Ensure there are written procedures available for IP Repackaging and Relabelling.
  • Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet.
  • Site staff involved in IP Repackaging and Relabelling should be trained accordingly.
  • A witness, who is part of the unblinded study team, should observe the IP Repackaging and Relabelling process.
  • Line clearance should be observed such that one type of IP is repackaged and relabelled at a time to avoid any mix up.
  • The quantity of the IP labels should be reconciled and documented on the IP Repackaging and Relabelling Form.
  • Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
  • The IP Inventory Logs should be updated for IP Repackaging and Relabelling.
  • The IP Repackaging and Relabelling Form should be filed in the Pharmacy Binder, where access is secure and limited to the unblinded study team in order to maintain the study blind.
  • All correspondences concerning IP Management that may potentially unblind the study should be limited to the unblinded study team.
  • The IP Repackaging and Relabelling Form should not be completed electronically.

Applicable References:

  • PICS Annex 13
IP Destruction Form Template

This template could be used to document the destruction of returned/ unused IP by the sponsor or site.

Useful tips:

  • Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet.
  • Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
  • The IP meant for destruction should be kept separately from the unused IP.
  • The IP Destruction Form should not be maintained electronically, unless the inventory is completed by a validated electronic system.

Applicable References:

  • GCP 4.6.3
IP Storage Temperature Log Template

This template could be used to record the IP storage temperature. It serves to document that the IP is stored according to the protocol.

Useful tips:

  • Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet.
  • Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
  • Ensure that the thermometer used for monitoring the IP storage temperature is calibrated and maintained regularly. Copies of the calibration and maintenance records should be filed in the Investigator Site File.
  • Record the serial number of the thermometer on the IP Storage Temperature Log for traceability purposes.

Applicable References:

  • GCP 4.6.4
IP Storage Temperature Excursion Report Template

This template could be used to report any deviation in the IP storage temperature to sponsor. It documents the details of the deviation and the response by sponsor.

Useful tips:

  • Site staff involved in IP management should be delegated by the Principal Investigator on the Signature Sheet.
  • Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.

Applicable References:

  • GCP 4.6.4

 

Investigator Site File (ISF) Templates

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Template Form Description
ISF Content Page
Investigator Site File Content Page

This template could be used to establish the Investigator Site File at the beginning of the trial. It contains the minimum list of essential documents which should be maintained for the clinical trial.

Useful tips:

  • Superseded essential documents (e.g. protocol, Investigator’s Brochure, Informed Consent Form templates) should not be removed from the Investigator Site File. A copy of the superseded essential documents should be marked ‘Superseded’ and retained in the Investigator Site File.
  • A note to file should be placed in the relevant section of the Investigator Site File if the essential document has been filed elsewhere.
  • Check that all essential documents are complete, accurate, legible and current.

Applicable References:

  • GCP 4.9.5, Section 8
Protocol
Protocol Signature Page

This template could be used to document the Investigator's agreement to the protocol and its amendments.

Useful tips:

  • Signed protocol signature page(s) should be present for the approved protocol and subsequent amendments used at the site.

Applicable References:

  • GCP 4.5.1, 8.2.2
Subject
Subject Identification Log

This template could be used to document the names of all subjects enrolled in the trial.

Useful tips:

  • The Subject Identification Log is a confidential document that should be maintained in the Investigator Site File. It should not be circulated to the Sponsor, IRB, HSA or other third parties.
  • Ensure that the Subject Identification Log is updated in a timely manner whenever a new subject is enrolled into the clinical trial.
  • Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.

Applicable References:

  • GCP 8.3.21
Subject Screening and Enrolment Log

This template could be used to document the subjects who had been screened and/ or enrolled for the trial.

Useful tips:

  • Ensure that the log is updated in a timely manner whenever there is a new subject screened/ enrolled into the trial.
  • Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.

Applicable References:

  • GCP 8.3.20, 8.3.22
Subject Visit Schedule Log

This template could be used to track the visit schedules for enrolled subjects. It serves to assist the site in ensuring that the subjects complete their study visits timely in accordance to the protocol.

Useful tips:

  • Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
Study Staff
Signature Sheet

This template could be used to document the roles, responsibilities and signatures of all site staff who have been authorised by the Principal Investigator to conduct trial-related duties.

Useful tips:

  • The Principal Investigator should ensure that the site staff is adequately qualified by education, training and experience to perform the delegated duties.
  • Site staff should be appropriately trained prior to conducting any study procedures.
  • Sub-investigators should only be included in the study team after written IRB approval has been sought.
  • It would be recommended that the task of obtaining informed consent be delegated to site staff who is a locally registered medical doctor / dentist, adequately qualified by education, training and experience to determine the subject's eligibility for enrolment into the clinical trial and address any questions that the subject may have in a satisfactory manner.
  • The Signature Sheet should be updated in a timely manner whenever there is a change to site staff and/ or delegated duties.
  • The name, initials and signature of the site staff on the Signature Sheet should be consistent with all other essential documents.
  • In the event of a change in Principal Investigator during the course of a clinical trial, it would be recommended to update the previously signed Signature Sheet with an end date for each site staff, and to complete a new Signature Sheet for the new Principal Investigator to authorise the site staff.
  • All versions, including superseded versions, should be present in the site file.
  • Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.

Applicable References:

  • Regulation 23(3) of the Medicines (Clinical Trials) Regulations and Health Products (Clinical Trials) Regulations 
  • GCP 2.8, 4.1.5, 4.2.4, 4.9.1, 8.3.24
Site Training Log

This template could be used to document the training received by site staff, so as to ensure that the site staff are adequately qualified to conduct trial-related procedures.

Useful tips:

  • Training records for all site staff delegated in the Signature Sheet should be present in the site file.
  • It would be recommended to file the following training documentation for all site staff in the Investigator Site File, where applicable:
    • Investigator Meeting
    • Site Initiation Visit
    • Collaborative IRB Training Initiative (CITI)
    • Good Clinical Practice (GCP)
    • Protocol-specific training

Applicable References:

  • GCP 2.8, 4.2.4
Tracking Logs
Serious Adverse Event (SAE) Tracking Log 

This template could be used to track the occurrence of serious adverse event (SAE) at site and the notification by site to IRB and/ or HSA of the SAE and related reports.

Useful tips:

  • Ensure that the safety reporting requirements are detailed in the protocol.
  • Ensure that SAEs are notified to the Sponsor, IRB and HSA (where applicable) in accordance with their respective safety reporting requirements.
  • Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
  • Ensure that the SAE Tracking Log is updated in a timely manner.

Applicable References:

  • Regulations 24 and 25 of the Medicines (Clinical Trials) Regulations and Health Products (Clinical Trials) Regulations
  • GCP 2.3, 4.11, 5.16, 5.17, 8.3.16-18
Regulatory Document Tracking Log 

This template could be used to track the submission and approval status of study documents submitted to IRB and/ or HSA. It serves to assist the site in ensuring that study documents are implemented only after appropriate approval has been obtained accordingly.

Useful tips:

  • Always check that the required approval for the study documents had been obtained prior to using them at site.
  • Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
  • Ensure that the log is updated in a timely manner.

Applicable References:

  • GCP 4.4.1, 4.4.3
Non-compliance Tracking Log 

This template could be used to track Serious Breaches* and other non-compliances in the clinical trial.

Useful tips:

  • Serious breaches* of the principles of GCP or trial protocol or clinical trials regulations must be notified to HSA.
  • Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
  • Ensure that the log is updated in a timely manner.

Applicable References:

  • Regulation 11 of the Medicines (Clinical Trials) Regulations and Health Products (Clinical Trials) Regulations
  • GCP 4.5.3

 

*A serious breach is a deviation which is likely to affect to a significant degree:
   a) The safety or physical or mental integrity of any subjects in a clinical trial; or
   b) The scientific value of the clinical trial.

Informed Consent Tracking Log 

This template could be used to track the versions of the informed consent forms which have been signed by subjects.

Useful tips:

  • Always check that subjects have been consented with the latest approved informed consent form in a timely manner. 
  • Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
  • Ensure that the log is updated whenever an informed consent form is signed.
Biological Sample Handling Log 

This template could be used to document the location and identification of the retained biological samples, as well as the accountability of the samples collected from subjects and shipped to sponsor.

Useful tips:

  • Amendments should be initialled and dated, and not obscured by overwriting or using correction tape.
  • Ensure that the log is updated in a timely manner.

Applicable References:

  • GCP 8.3.25