January 2006
FORMS
ANNEX 7a - Page 1 of 2
Extension of Approval of the Director of the Medical Institution to Perform a Medical Trial in Humans
Date: _______________
Dr. XXX
XXXX
Dear Prof/Dr,
Subject: Extension of Approval for carrying out a clinical trial on human subjects
Further to your request dated ______, an approval is hereby granted for the conduct of the clinical trial, in
accordance with the study protocol attached to the application.
Helsinki Committee Submission No.:
MOH Submission No.:
Name of Medicinal Product:
Name of Manufacturer:
NIH site
number:
registration
Study Title:
Protocol No.:
Version:
Date:
Informed Consent Version:
Date:
Investigator's Brochure (if available): Version:
Date:
Name of Principal Investigator:
Department:
Name and address of Sponsor:
Name and address of Sponsor's representative:
Pursuant to the authorization conferred on me by the Director General of the Ministry of Health, to issue, in
my capacity as “Director”, approval to conduct a clinical study on human subjects, in the Tel-Aviv Sourasky
Medical Institution, after the application has been approved by the Helsinki Committee of the institution on
________ and after the application has been approved by the Ministry of Health* on (date)_____ and having
been convinced that the study is in accordance with the principles of the Declaration of Helsinki and with the
Public Health Regulations (Medical Experiments on Human Subjects)-1980, and that the contract between
the sponsor, the principal investigator, and the medical institution, is in full compliance with the requirements
of the guidelines for the conduct of clinical trials on human subjects-1999, I hereby approve the conduct of
the trial, subject to conditions as set out in the Terms of Approval.
TERMS OF APPROVAL
1)
The clinical trial shall be conducted in accordance with the principles of the Helsinki Declaration, the
guidelines for the conduct of clinical trials on human subjects in Israel (2005), and the current
international guidelines.
2)
The treatment shall be given only after an explanation has been provided to the participant or to
his/her legally appointed representative, and after he/she* has duly signed the informed consent form
attached to the application.
3)
Any change in, addition to, or deviation from, the study protocol, requires written approval of the
Helsinki Committee of the medical institution and/or of the Ministry of Health.
4)
The principal investigator of the trial shall report to the Helsinki Committee of the medical institution
and to the sponsor of the study, on any unusual serious adverse event which became apparent during
the course of the trial (as detailed in item 15.1.1. of the guidelines), or on discontinuation of the trial. The
institutional Helsinki Committee shall investigate the event and forward their opinion to the Ministry of
Health.
January 2006
FORMS
ANNEX 7 - Page 2 of 2
Extension of Approval of the Director of the Medical Institution to Perform a Medical Trial in Humans
5)
Extension of the trial: Two months prior to trial approval period termination, the principal investigator
is obliged to report on the progress of the trial to the Helsinki Committee of the medical institution. The
committee shall advise the Director of the medical institution on their decision with regard to continuing
the trial. The Director shall issue a new approval for the trial.
6)
Upon termination of the trial, the principal investigator shall submit to the Helsinki Committee a report
summarizing the course of the trial and the results thereof.
7)
The approval is granted to the aforementioned principal investigator and to the medical institution,
and it may not be transferred to other parties.
8)
Medical trials which involve providing services: conducting medical tests or supplying equipment,
medicinal products or implants, the investigator is obligated to inform the general practitioner treating the
patient of his/hers participation in the trial.
9)
It is not permitted to publish any information relevant to the trial in the public media such as
newspapers, radio, television, internet, except for publication meant to recruit participants for the trial.
Publication is, however, permitted in scientific journals and at scientific conferences.
10)
The supply of the investigational product/medical device* to the medical institution which participates
in the trial, is the responsibility of the sponsor. Storage and dispensing the investigational
product/medical device to the participants in the trial, fall within the responsibility of the principal
investigator. In the case of medicinal products, these actions shall be performed in coordination with the
pharmacy of the institution, unless otherwise decided by the Helsinki Committee.
11)
12)
Medicinal products, duly registered in Israel, shall be dispensed by the pharmacy of the institution.
Documents: all request forms, approvals and all other documents collected during the clinical trial
must be stored for at least 15 years after trial termination.
13)
Additional Restrictions: ___________________________________________
14)
Validity of the approval:
Good Luck!
Yours faithfully,
Director of the Medical Institution
cc: Pharmacy Manager of the institution
The Sponsor/ his representative
Chairman of the Helsinki Committee
of the Medical Institution