Code Number (For Official Use Only)


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


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


Principal investigator for single centre research

Coordinating investigator for multi centre research

Person / organisation authorised by the sponsor

Person or organisation name


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



Healthy volunteers


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



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


Contact person name

Telephone number

Details of functions which are carried out by third parties – Tick as appropriate

All tasks of the sponsor


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


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