Clinical Trials in

Direction de la Pharmacie et du Médicament Clinical Trials in Tunisia

* Decree n° 90-1401 of 3 septembre 1990 fixing the modalities of the medical or scientific expérimentation for human medecines

*Decree n° 2014-3657 of 3 octobre 2014 amending the previous one : * Healthy volonteer * Minors: underage (with scientific justification) * Regional committee for human protection (CPP) Submission of Clinical Trials in Tunisia

• Online application to receive « Unique National Number » for Clinical Trials registration in the DPM web site • Parallel submission for both CPP & DPM (both approvals required) •Submission for the INPDP ( Instance Nationale de Protection des Données des Personnes ) •Timelines 4 to 12 weeks ( for CPP and DPM approval) Submission of Clinical Trials in Tunisia

Comitee of Human Protection (CPP): Informed Consent, Protocol , IB Suitability of investigators Financial compensation …..

Online registration on the DPM site Unit of Pharmacy and Drug (DPM): Decision Proctocol, IB ,IMP Quality and labelling ,Suitabilty of ce nters , Contracts ……

INPDP : National Instance for Personnel Data Protection

Informed consent … Submission of Clinical Trials in Tunisia 1 Online application www.dpm.tn

2 Submission of files in parallel to CPP / DPM

3 Assessment by both entities

4 Sponsor has to answer the raised issues by CPP or DPM

5 Favorable opinion of CPP

6 DPM (approval or rejection ) Approval of Clinical Trials in Tunisia

CPP Approval

DPM Approval

Approval of the IMP Importation by DPM (within 48 hours )

Custom clearence Regional committees for human protection ( CPP)

*Ministerial decision (2015) •Set up of Regional committee for Human protection (CPP) for the assessment of clinical trials on human defining their : • Attributions ,composition and Operational procedures Parallel Submissi DPM (MOH)

CPP of the National Study Investigator

Clock start from the date of receipt of full app Approval ~4 weeks to 12 weeks lication of the study Regional committees for human protection ( CPP) Northern CPP : Grand , Zaghouan, Béja, , et Central CPP: , Monastir, , , , SidiBouzid, et Southern CPP : , Gabes, , , Médenine, Kebelli Regional committees for human protection ( CPP) :Attributions

-Give an opinion on clinical trials on human

- Make sure that the protection of participants in the medical experimentation is ensured, that research is relevant and that the evaluation of the ratio between benefit and risk is favorable Regional committees for human protection ( CPP) :Attributions -Ensure the adequacy, completeness and the intelligibility of the written information provided by sponsor as well as the procedure followed to obtain the informed consent of the participants

-Check the recruitment procedures of the participants ,the amounts and terms of their compensation . -Give an opinion on changes Regional committees for human protection Composition

However, the President may invite nonmembers with expertise in special areas for assistance. Regional committees for human protection ( CPP) : Quorum The CPP makes its decisions at his meetings at which at least a quorum, as stipulated , is present and which is : - 9 members besides the president or vice president . Distributed between the two colleges At least one qualified person in biostatistics or epidemiology At least one represantative of the patient associations and/or people used to healthcare system Regional committees for human protection ( CPP) : Protocol overview

The comittee check every point in the protocol in order to : - To safeguard the rights, safety, and well-being of all trial subjects. - The study is relevant and that the ratio between Benefit and risks is favorable Conclusion

Why Tunisia to conduct a clinical Trial :

-Legislation that is clear and strict -Human ressources : investigators with experience in clinical trials