Code Number (For Official Use Only)
HEALTH ETHICS COMMITTEE
Application form for clinical trials other than
of medicinal products
Code number (for official use only)
Research identification
Tick as appropriate
Clinical research
Experimental research
Research involving investigational medical devices
Research involving investigational surgical procedures
Undergraduate dissertation
Specify course
Postgraduate research
Specify course
Other (please specify)
Full title of the research
Protocol code number, version and date
ISRCTN number, if applicable
Sponsor identification
Is the research funded in any way by industry ? Yes / No
Organisation name
Address
Work telephone numbers
Fax number
Email address
Contact person name
Applicant details - These are the details of the legal applicant who signs the form. The contact person may be a different individual at the same location / organisation. The phone, fax and email should be those of the contact person.
Tick one
Sponsor
Principal investigator for single centre research
Coordinating investigator for multi centre research
Person / organisation authorised by the sponsor
Person or organisation name
Address
Contact person name
Telephone numbers of home and places of work
Fax number
Email address
General information
Specify the medical condition (if applicable)
Main objective of the research
Secondary objectives of the research (if applicable)
Principal inclusion criteria
Principal exclusion criteria
Primary end points
Estimate of the duration of the research from to
Design of the research
Sampling (give details if applicable)
Non-invasive (ex. ultrasound)
Minimally invasive (ex. venipuncture)
Invasive (ex. surgery)
Potential risks
Potential benefits
Balance of risks and benefits
Confidentiality safeguards
State sites where research is going to be carried out
Population of subjects
Age span
Tick as appropriate
Male
Female
Healthy volunteers
Patients
Women of childbearing potential
Pregnant women
Nursing women
Emergency situations
If yes, specify
Subjects incapable of giving informed consent
If yes, specify
Other vulnerable populations
Planned number of subjects
Investigator details (copy and fill in for each investigator / supervisor)
Tick one
Principal investigator for a single centre research
Coordinating investigator for a multi centre research
Other principal investigator for a multi centre research
Associate investigator
Name
Profession
Institution name
Institution department name
Institution address
Telephone numbers of home and places of work
Mobile number
Pager number
Fax number
Email address
Sponsor’s duties which are carried out by third parties (if applicable)
Organisation name
Organisation department
Address
Contact person name
Telephone number
Details of functions which are carried out by third parties – Tick as appropriate
All tasks of the sponsor
Monitoring
Data management
Treatment randomisation
Medical writing
Quality assurance auditing
Investigator recruitment
Other duties
Declaration by the applicant
(including terms and conditions for approval in terms of the Data Protection Act)
Study title
I confirm that / confirm on behalf of the sponsor that (delete as appropriate):
All information submitted in this form and appended documentation is true and correct.
Any changes occurring during the study (including documents) shall be submitted to the Health Ethics Committee if so required by the same ethics committee. This may necessitate an authorisation before such a change can be implemented. In this case all documentation pertaining to the amendment which is submitted shall be true and correct.
The end of study report will be submitted to the Health Ethics Committee within 15 days from finishing.
The study will be conducted according to the protocol and applicable requirements including data protection as deemed necessary by the Health Ethics Committee including data protection.
Personal data shall only be collected and processed for the specific research purpose.
The data shall be adequate, relevant and not excessive in relation to the processing purpose.
All reasonable measures shall be taken to ensure the correctness of personal data.
Personal data shall not be disclosed to third parties who are not signatories and may only be required by the Health Ethics Committee or the supervisor/sfor verification purposes. All necessary measures shall be implemented to ensure confidentiality and where possible, data shall be anonymised.
Unless otherwise authorised by the Health Ethics Committee, the researcher shall obtain the consent from the data subject (participant/respondent) and provide him with the following information: The researcher’s identity and habitual residence, the purpose of processing and the recipients to whom personal data may be disclosed. The data subject shall also be informed about his rights to access, rectify, and where applicable erase the data concerning him.
The Health Ethics Committee may process my personal data for the purpose of evaluating my request and other matters related to this application. I also understand that I can request in writing a copy of my personal information. I shall also request rectification, blocking or erasure of such personal data that has not been processed in accordance with the Act.
Signature of applicant (as stated in page 2) ______
Print name ______Date ______
Code number
FOR OFFICE USE ONLY
The Health Ethics Committee has considered the application for the study entitled
to be valid / not valid for the following reasons:
Validation officer Date
The Health Ethics Committee has found the study satisfactory / unsatisfactory for the following reasons:
Reviewer Reviewer
Date
1
MINISTRY FOR HEALTH