Friday, March 25, 2011

Registration of herbal trials in CTRI is not mandatory

A trial patient visited the site complaining breathlessness and tachycardia. The investigator advised hospitalization but as subject could not afford the expenses, he refused for admission. Is this an SAE because investigator advised hospitalization?
G Praveen Kumar.

If the patient was not hospitalized, it does not fall into SAE criteria of hospitalization. However, it appears from your mail that the PI felt that the event was serious enough to admit the subject for treatment. This makes it an “important medical event." As per ICH E2A such event also are considered serious. See the ICH E2A excerpt below:

Medical and scientific judgement should be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the patient or may require intervention to prevent one of the other outcomes listed in the definition above.  These should also usually be considered serious.

There is also one more problem here. As per Indian GCP, and recent DCGI directive, the cost of medical treatment has to be covered by the sponsor. Hence, the PI should have treated the patient free of charge and recovered the cost from the sponsor.

How often should the ICF be updated considering there are CIOMS generated on an ongoing basis during the course of a trial?

Health ministry upgrades CTRI with new features to cope with momentum in registration

In order to cope up with the momentum in registration of clinical trials in the country which has been picking up fast ever since registration of clinical trials was made mandatory by the DCGI from June 15, 2009, the Union Health Ministry has upgraded the Clinical Trial Registry of India (CTRI) with several new features.

In the upgraded version, the CTRI has incorporated new features on audit trial, submission of EC-DCGI approval documents, trial transfer, trial search, etc.

In the new software application, once a trial is registered, all fields would be automatically 'locked' except for 'Recruitment status of trial'. In case changes are desired to be made, request has to be sent to the CTRI, quoting CTRI registration number, indicating the field that is to be changed. Accordingly, only the desired field will be 'unlocked' and once changes have been incorporated, the field will again become 'locked'. Further, all these changes will be available for public view, under 'Modifications' when a trial is viewed in the public domain. Uploaded documents if any are not visible in the public domain, although registrant may be able to view it upon login to CTRI.

For pre-registered trials, all fields remain unlocked except for those trials where Ethics Committee and DCGI approvals have been obtained. Registrants are encouraged to upload any additional information according to the new data. However, these changes will also be visible in the public domain under 'Modifications.'