10. Roadmap of the Submission Process of a Clinical Trial

10.1 Clinical Trial with Investigational Medicinal Product

See the Regulatory Process for Interventional Clinical Trial approved by the MOHAP and Ethics Committee (see page 25 of the “Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices”).

10.2 Pediatric Investigation Plan (PIP)

From the research conducted, no specific guidance was found in relation to PIPs. What is implied is that trials involving pediatric participants are subject to the same application process and approval procedure as clinical trials, though the informed consent will be subject to the requirements for minors discussed in Section 9 of this guidebook.

10.3 Clinical Study (Interventional or Observational)

Paragraph 2.28 of the Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices defines “Non-Interventional study” as “a study fulfilling cumulatively the following requirements: 

a) The medicinal product is prescribed in the usual manner in accordance with the terms of the marketing authorization.

b) The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study.

c) No additional diagnostic or monitoring procedures are applied to the patients and epidemiological methods are used for the analysis of collected data. 

The terms non-interventional study (NIS) and observation study (OBS) are synonymous.”

“Article 37. For clinical trials with non-interventional design, these may begin when the following conditions are fulfilled: 

1. the Ethics Committee (REC or LEC) has given a positive opinion, and 

2. the Regulatory Committee at the Ministry of Health and Prevention (RCMOHP) has been notified in writing prior to the first subject being enrolled."

Regulatory Process for Non-Interventional Clinical Trial approved by Central or Local EC. (see page 25 of the “Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices”).