PROTOCOL AMENDMENT:

  • The submission of amendments and related documents, must be presented to MoH -INVIMA-, including the approval letter of at least one Research Ethics Committee.
  • INVIMA will evaluate and issue a concept for these documents and provide a general approval, but not an approval for each site.
  • When the same amendment applies to other sites, the approval letters of the Research Ethics Committees that has not been submitted in the initial submission of this document, does not need to be notified to MoH-INVIMA.
  • If any Research Ethics Committee denies the amendment and the documents related, this situation must be informed immediately to INVIMA, no later than 5 WD, since the sponsor/CROs became aware of it.
  • If a site has an specific version of the informed consent linked to the amendment, due to specific requirements of the Research Ethics Committee which differs from the general version, and these dif ferences are version and date, it must be submitted to MoH-INVIMA for its approval.
  • When the studies are approved in reference countries, it will be possible to carry out a shortenedevaluation procedure for the amendments, but this decision is under Clinical Research Group responsibility: INVIMA will proceed as follows:-Sending emails to sponsors requesting information from the reference countries and / or including in the submission form thisrequest (comments to sponsor).
  • If the amendment has not been approved in any ref erence country, it should be evaluated under the regular process.
  • The evaluation of informed consents will be performed under the regular process.

ICF:

  • When an informed consent approved inthe initial protocol, is included in the approval submission for a new site (same content, title and version), this information must be includedin the corresponding format;
  • Additionally Approval Letter of the Ethics Committee, stating the title of the ICF and the approved version, must be included in the format. In this case, it is not necessary to add the informed consent document, in the submission package.

For more informarmation, please see the original communication from INVIMA in local language or consult the English translation (courtesy of Meditrial).

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