Preclinical and Clinical Trial Requirements
The key facts about preclinical and clinical trial requirements in Venezuelan Pharma. Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, available to purchase here for USD 99.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
2. How are clinical trials funded?
Clinical trials are funded by those interested in obtaining the product’s marketing permit.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
Clinical trial protocols must include:
- Protocol title, protocol identification number and date. Any amendment must also have a number and date;
- Research phase;
- Name and address of the sponsor and the monitor;
- Name and title of the person authorized by the sponsor to sign the protocol and amendments
- Name, title, address and number of the expert’s doctors or dentists of the trial sponsor;
- Name and curriculum vitae of the researcher responsible for the carrying out test and the address of the test location;
- Name, curriculum vitae, address and telephone number of the qualified physician or dentist responsible for decisions medical or dental related to the test site (if It does not match the investigator);
- Name and address of the clinical laboratory and others medical and / or technical departments and / or institutions involved.
- Summary of the protocol.
The National Institute of Hygiene is the governmental entity that approves the protocol.
4. What are the requirements for consent by participants in clinical trials?
The consent of the informed party is a process by which a subject voluntarily confirms his/her desire to participate in a clinical trial, after having been adequately and in detail informed about all the relevant aspects of the investigation and that are of their interest for the taking of That decision.
Prior to the participation of the parties in a clinical trial, their voluntary consent must be obtained from each of them or by their respective legal representatives after having been informed in detail of all the aspects that are relevant to said decision.
The participant’s consent will be documented by means of a written, signed and dated form.
Any information or written document used for the consent process must be previously approved by the Ethics Committee.
The form for the written consent of the informed subject and any other written information to be delivered to the subjects must be reviewed when new information arises that could be relevant to their consent. Said information must have the prior approval of the Ethics Committee and be communicated in due course to the subject or to the legally accepted representative. The communication of this information must be documented.
Neither the investigator nor the trial staff shall force, coerce or unduly influence a subject to participate or continue their participation in an essay.
The investigator or his designee must fully inform the subject or his legally accepted representative of all relevant aspects of the trial.
The language used in the written and verbal information about the essay should be practical and not technical and the subject, his legally accepted representative and the impartial witness, when appropriate, should understand it. In case that the subject’s language was not currently used in the country or community, the information to the subject and the consent must be provided in their language.
Before obtaining the informed subject’s consent, the investigator or his designee must give the subject or his legally accepted representative enough time and opportunity to ask about the details of the essay and to decide whether or not to participate in it.
All questions about the essay should be answered to the satisfaction of the subject or his legally accepted representative.
Before a subject participates in the trial, the consent form must be signed and dated by the subject himself or by his legally accepted representative and by the person who led the discussion of consent.
5. May participants in clinical trials be compensated?
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
The consent of the participant must include a compensation clause indicating that, with the signature of this, the subject is automatically protected by an insurance policy and / or a written record in which the sponsor declares that he assumes the responsibility of covering all medical expenses that occur as a result of any damage or injury related to the trial.