| (1) | A person desiring to initiate or conduct a clinical trial shall apply, on an application form obtainable from the office of the Chief Executive Officer, to the Authority for authorisation to conduct such a clinical trial. |
| (2) | An application for a clinical trial shall be accompanied by a prescribed fee and contain at least the following information: |
| (a) | Clinical trial protocol; |
| (b) | investigator's brochure containing relevant chemical, pharmaceutical, pre-clinical pharmacological and toxicological data and where applicable, human or animal pharmacological and safety and efficacy clinical data about the medicine concerned; |
| (c) | professional information pertaining to all registered medicines used in the trial or the international equivalent thereof if the medicines are not registered in South Africa; |
| (d) | the details of the investigators who will be responsible for the sites where the trial is to be conducted and, in each case, who shall be— |
| (i) | an appropriately qualified and competent person; |
| (ii) | registered with the relevant statutory health council, where applicable; and |
| (iii) | resident in the Republic; |
| (e) | Curriculum Vitae of all investigators stipulated in terms of paragraph (d); |
| (f) | proof of current training in Good Clinical Practice of all investigators; |
| (g) | in the case of trials involving human participants, proof of current, relevant and appropriate— |
| (i) | study insurance for all participants undertaken by the applicant referred to in subregulation (1); and |
| (ii) | professional indemnity insurance for investigators; |
| (h) | details of the site(s) where the trial is to be conducted; |
| (i) | signed declaration by the applicant referred to in subregulation (1) and all investigators of the trial that they are familiar with and understand the protocol and will comply with Good Clinical Practice as determined by the Authority in the conduct of the trial; |
| (j) | participant information form and informed consent documents in the case of human trials or owner consent document in the case of animal trials; |
| (k) | approval of the clinical trial by— |
| (i) | any health research ethics committee registered with the National Health Research Ethics Council in terms of the National Health Act, 2003 (Act No. 61 of 2003); or |
| (ii) | in the case of research on animals, an Animal Ethics Committee, which must conform to SANS 10386:-2008; and |
| (I) | any other information as may be required by the Authority. |
| (3) | In the case of an application for a clinical trial in respect of a registered medicine, a registered indication or registered dosage regimen of a registered medicine or substance, subregulation (2) shall apply to the information contained in the application: Provided that it shall be sufficient to contain in the application form particulars referred to in subregulation (2)(a), (c), (d), (f), (h), (i), (k) and (I). |
| (4) | Clinical trials shall be conducted in accordance with guidelines for good clinical practice as may be determined by the Authority from time to time. |
| (5) | No person may conduct clinical trials referred to in subregulation (1) without the authorisation of the Authority. |
| (6) | The person authorised by the Authority to conduct the clinical trial referred to in subregulation (1) shall submit— |
| (a) | progress reports to the Authority every six months from the date of approval of an application and 30 days after the completion or termination of the clinical trial; |
| (b) | a development safety update report annually and the final safety report 30 days after the completion or termination of the clinical trial; and |
| (c) | a final study report within 180 days of the completion or termination of the clinical trial. |
| (7) | The principal investigator shall inform the Authority of any— |
| (a) | suspected adverse events; or |
occurring as a result of the use of any medicine during the conduct of a clinical trial.
| (8) | A person desiring to amend the protocol of a clinical trial referred to in subregulation (1) shall apply to the Authority together with the prescribed fee for the evaluation and authorisation related to such amendment. |
| (9) | Medicines referred to in subregulation (1) shall be properly labelled and the package shall sufficiently identify the— |
| (a) | clinical trial to be carried out; |
| (b) | medicine(s) to be used; |
| (c) | participant number to whom the medicine is to be administered or in the case of animals the name of the person under whose supervision it is to be administered; |
| (d) | name and address of the site where the clinical trial is conducted; |
| (e) | the directions in regard to the manner in which such medicine should be used; |
| (h) | any other information as may be required by the Authority. |
| (a) | request additional information; |
| (b) | inspect a clinical trial site; or |
| (c) | withdraw the authorisation to conduct a clinical trial, |
if the Authority is of the opinion that the safety of the participants of the trial may be compromised or that the scientific reasons for conducting the trial have changed or if the integrity of the data is compromised.
