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What is the authorisation procedure for conducting clinical trials in your jurisdiction?
The authorisation procedure for conducting clinical trials in Colombia is regulated by Resolution 2378/2008. To initiate a clinical trial, the party must request approval from the National Food and Drug Surveillance Institute (INVIMA) and fulfil, among others, the following requirements:
- The party has received an approval letter issued by an INVIMA-registered research ethics committee.
- The party has received approval from a local health authority confirming that the investigation centre is suitable to provide health services.
- The party has received a certificate of good clinical practice issued by the INVIMA (valid for five years).
- The party has in place an insurance policy to cover third-party damages (to cover possible adverse events associated with or attributable to the clinical trial).
- The party can provide a robust research protocol (including the operation methodology, theoretic framework, justification, results analysis plan and patient data management).
How robust are the standard good clinical practices followed in your jurisdiction?
The INVIMA bases its regulations and practice on global clinical standards (set by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use and the World Health Organisation) and verifies that institutions that carry out research on human beings must comply with the good clinical practice adopted through Resolution 2378/2008. The competence and responsibilities of the ethics committee which issued the approval letter for the research as well as those of the investigator will be assessed in depth. The processes, documentation and registrations associated with the project and of the clinical labs will be also evaluated.
In addition, research centres must follow the dispositions of Resolution 8430/1993, which establish the rules for performing health investigations in Colombia, as well as Resolution 1995/1999, which contains rules for managing clinical records. The personnel responsible for the storage and handling of medicines must comply with the dispositions of Decree 2200/2005 and 1403/2007, which include rules covering pharmaceutical services. In addition, according to Resolution 20764/2011, periodic reports on any adverse events attributable to an investigational drug must be created.
Reporting, disclosure and consent
What are the reporting and disclosure requirements for the results of clinical trials?
Resolution 2378/2008 requires that the results of every clinical trial (both favourable and unfavourable), whether the trial itself is finalised or abandoned, must be reported to the INVIMA.
The principal trial researcher must submit written summaries covering the status of the study to a research ethics committee at least once a year or more frequently if the committee requires it.
The researcher must notify the INVIMA of any significant change that affects the conduct of the trial.
The researcher is responsible for ensuring that the study data is disseminated among the scientific community, regardless of whether the results are favourable, for the therapies under study.
What are the informed consent obligations with respect to clinical trial subjects?
Resolution 8430/1993 establishes that informed consent obligations include providing clinical trial subjects with information on:
- the investigation objectives;
- the procedures that will be used;
- any inconveniences and expected risks;
- the benefits that may be obtained; and
- any alternative procedures that could be advantageous for the research subject.
In addition, clinical trial subjects must:
- receive answers to any questions and doubts;
- be free to withdraw consent and to stop participating in the study;
- have patient confidentiality;
- be provided with updated information obtained during the study;
- be given medical treatment if any injuries arise as a result of the investigation; and
- be reimbursed for any additional expenses, which should be covered by the budget of the investigation.
What are the insurance requirements for clinical trials?
According to Resolution 2378/2008, to safeguard the fundamental rights of research subjects, civil liability insurance for damage caused to third parties must be put in place. The insured value should be determined according to international standards. In the event that the insurance does not completely cover the damages, the promoter, clinical trial investigator and/or the head of the institution or centre in which the trial was carried out are jointly and severally liable.
What data protection issues should be considered when conducting clinical trials?
Under the Colombian Data Privacy Law (1581/2012), clinical trial data is considered a special data category as it contains health and personal biometric data. The trial subject must sign an informed consent form, which clearly states what data is being collected and for what purpose.
Clinical trial providers must identify:
- the data that is being processed;
- who processes the data;
- where the data is transferred; and
- any other risks and relevant processes associated with the data.
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