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.
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:
- 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
- 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.