<Sponsor letter head>
<Date>
NOTIFICATION OF SPONSORSHIP ARRANGEMENTS FOR MULTI-SITE (SINGLE PROTOCOL) INVESTIGATORINITIATED TRIALS
Dear Sir or Madam:
We would like to provide this letter as a notification of the sponsorship arrangement for the following study
<PRISM transaction/application number (if available)>
<Protocol title>
<Protocol number>
The lead and participating site sponsors for the above referenced protocol are listed below.
Lead Sponsor
Participating Site
Sponsor(s)
<Lead sponsor>
<Address>
<Participating site sponsor>
<Address>
<Name of lead PI>
<Name of participating site PI>
The lead sponsor:
1.
2.
3.
4.
Is responsible for the ongoing safety evaluation of the study drug(s) administered to a subject in a
clinical trial [reference - SGGCP Section 5.16.1]
Shall promptly notify all participating site investigators/institutions of findings that could adversely
affect the safety of subjects or impact the conduct of the trial [reference – Section 5.16.2]
Is responsible for the notification of unexpected serious adverse drug reactions [reference – Section
5.17.1], and serious breaches of the Singapore Guideline for Good Clinical Practice (SGGSCP) or the
trial protocol, to the Health Sciences Authority in accordance with applicable regulatory
requirements
Is responsible for all trial-related regulatory submissions and notifications to the Health Sciences
Authority (e.g. applications for CTC, protocol and informed consent amendments, addition of trial site,
change of principal investigator, trial status report, final trial report etc)
The participating site sponsor:
1.
2.
Shall ensure that any serious adverse event which occurs in a subject during a clinical trial conducted
at the participating site, or any finding that could adversely affect the safety of subjects or impact the
conduct of the trial, is immediately reported to the lead sponsor
Shall provide all relevant information to the lead sponsor that is necessary for the lead sponsor to
perform trial-related regulatory submissions and notifications to HSA.
Lead sponsor declaration form_Version 6.0 15 Oct 2014
Page 1
DECLARATION OF LOCAL SPONSOR
I shall abide by the Medicines Act 1975, the Medicines (Clinical Trials) Regulations 1978, the Medicines (Clinical Trial)
(Amendment) Regulations 1998, the Singapore Guideline for Good Clinical Practice and any other conditions imposed by
the Health Sciences Authority in the conduct of the clinical trial.
I confirm that the information submitted in this application is true and accurate at the date of submission of the application.
I confirm that all manufacturing and assembly operations are carried out under GMP conditions.
I shall inform the Health Sciences Authority of any changes to the information submitted in the application.
My firm/My company undertakes to indemnify the Government/the Hospital against all actions, claims or proceedings in
respect of any injury to or death of any person whomsoever arising out of or in connection with the carrying out of the
clinical trial unless such injury or loss be due to the negligence of the hospital or any of its employees.
I shall be responsible for the ongoing safety evaluation of the study drug(s) administered to a subject in a clinical trial.
I shall promptly notify all participating site investigators/institutions of findings that could adversely affect the safety of
subjects or impact the conduct of the trial.
I shall be responsible for the notification of unexpected serious adverse drug reactions and serious breaches of the
Singapore Guideline for Good Clinical Practice (SGGSCP) or the trial protocol to the Health Sciences Authority in accordance
with applicable regulatory requirements.
I shall be responsible for all trial-related regulatory submissions and notifications to the Health Sciences Authority.
Signed on behalf of
and witnessed by
__________________________
Name of Contact Person
__________________________
Name of Witness
__________________________
Signature
__________________________
Signature
__________________________
NRIC No. /Foreign Identification No.*
__________________________
NRIC No. / FIN.*
__________________________
Designation in Sponsor Company
__________________________
Designation in Sponsor Company
__________________________
Date
__________________________
Date
*Delete where applicable
Lead sponsor declaration form_Version 6.0 15 Oct 2014
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