Sidebar

RESEARCH

Resources for Clinical Research Studies (For Internal Login Only)

 

Welcome to the CRU Resources page!

Here, you will find all the templates required for Site Investigator File (SIF) and some self-help checklists.

  1. Templates for Site Investigator File (SIF) -> click to view templates in SharePoint and direct to the doc.

  2. Self-help checklists:

 

Templates for Site Investigator File (SIF)

An Investigator Site File (ISF) should be generated at the start of every clinical trial or clinical research. The ISF contains the minimum list of essential documents (see below for templates) that must be maintained throughout the clinical trial or research.

Click here to view the ISF Checklist and other templates to be filed in the ISF (if required).

Disclaimer: These templates serve to guide your clinical trial or clinical research processes. You may customise the templates to suit the needs of your clinical trial or research (if necessary).

1. STUDY TEAM
Template Purpose
1.1 Contact details of study members To document the study team members’ contact details.
1.2 Study responsibility or delegation log To document the roles, responsibilities and signatures of all site staff whom the Principal Investigator has authorised to conduct trial-related duties.
1.3 Training record form To document the training received by site staff to ensure that the site staff are adequately qualified to conduct trial-related procedures.
1.4 Study initiation meeting attendance log To document the first study meeting and any interim meeting discussion.
1.5 Conflicts of interest (COI) declaration To file study team members’ COI annually.

 

2. STUDY DOCUMENTS (Note: Original copies and amended versions of all approved study documents must be filed.)
Template Purpose
2.1 Protocol Signature page

To document the Principal Investigator's agreement to the protocol and its amendments.

Signed protocol signature pages should be present for the approved protocol and subsequent amendments used at the site.

2.2 Protocol and Informed Consent Form Tracking Log (IRB) To track all protocol approval and amendment. To ensure that the latest version is used for the study.
2.3 Informed Consent Form Informed Consent Form for English-speaking subjects.
2.4 Short consent form (Chinese) Short Chinese Consent Form for non-English speaking subjects.
2.5 Short consent form (Malay) Short Malay Consent Form for non-English speaking subjects.
2.6 Short consent form (Tamil) Short Tamil Consent Form for non-English speaking subjects.
2.7 Short consent forms tracking log To track all the approved short consent forms.
2.8 Assent consent form For subjects who are 6 -12 years old.
2.9 Assent consent forms tracking log To track all the approved assent consent forms.

 

3. INSTITUTIONAL REVIEW BOARD (IRB) DOCUMENTS
Template Purpose
3.1 Non-compliance / protocol deviation tracking log To track serious breaches and other non-compliances in clinical trials or research.

 

4. REGULATORY DOCUMENTS (HSA), IF APPLICABLE
Template Purpose
4.1 Protocol and Informed Consent Form Tracking Log (HSA) To track all protocol approval and amendment. To ensure that the latest version is used for the study.

 

5. SUBJECT STUDY LOGS AND SIGNED INFORMED CONSENT DOCUMENTS
Template Purpose
5.1 Eligibility Checklist To ensure the subject fulfills all the inclusion and exclusion criteria according to the latest approved protocol.
5.2 Subject Screening and Enrollment Log To document the consent and screening of all subjects and the outcome of each screening.
5.3 Subject Identification Log To document the names of all trial participants enrolled in the trial. It 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.
5.4 Subject visit schedule log To keep track of subject visits and subsequent visits according to the latest approved protocol.
5.5 Subject Informed Consent Tracking Log To track the versions of the informed consent forms which subjects have signed.

 

6. SAFETY REPORTS
Note: Kindly contact CRU for discussion before the study team submits safety report(s) to IRB or HSA.)
Template Purpose
6.1 Adverse event form To document all the adverse events of a single subject in the study.
6.2 Documentation AE/SAE in Clinical Notes To document AE/SAE in the clinical note so the primary care team will be informed about the event.
6.3 UPIRTSO Tracking log To track Unanticipated Problem Involving Risk to Subject and Others.
6.4 AE and SAE tracking log To track Adverse Event (AE) / Serious Adverse Event (SAE).

 

7. INVESTIGATIONAL PRODUCT (IP)

Note:

  1. Documents may need to be kept in a separate file to maintain IP blinding for double-blinded clinical trials.
  2. Kindly contact CRU to review the IP documents before study initiation.
Template Purpose
7.1 IP inventory log To record IP inventory.
7.2 IP dispensing and accountability log To record each subject’s use of the IP and ensure that subjects were provided with the doses specified by the protocol.
7.3 IP re-labelling and re-packaging form To record IP re-labelling and re-packaging details.
7.4 Temperature Log To record IP storage temperature if IP is temperature sensitive.
7.5 IP Destruction Form To record IP return and/or IP destruction.

 

8. LABORATORY / BIOLOGICAL SPECIMEN MANAGEMENT
Template Purpose
8.1 Biological Specimen Log To record specimen collection and transfer.
8.2 Temperature log Temperature log for specimen storage
8.3 Destruction records (if samples are destroyed after study completion) To record samples destroyed procedure

 

9. FINANCE DOCUMENTS
Template Purpose
9.1 Reimbursement Tracking Log To document that subject has received the reimbursement according to the approved protocol.

 

10. OTHER DOCUMENTS
Template Purpose
10.1 Note to File To describe and document deviations, problems, or events occurring during the conduct of research which cannot be documented in a standard case report (CRF) form or research record.