Note: For unlocking of fields in registered trials, kindly follow the SOP described below. Also refer to the guidelines mentioned above the "Registered Trials" page on the CTRI portal.
1. Site Addition / Deletion
- Upload EC/DCGI approval for addition or deletion of the site under the Ethics Approval section. This field is permanently unlocked.
- Send an email(ctri@gov.in) requesting site unlocking and mention the list of new site PIs in the mail quoting the CTRI number in subject line of mail.
- For sites without EC approval, mark a copy of the mail to the PI(s), requesting them to send a confirmation email to the email ID(ctri@gov.in) regarding their participation in the trial.
2. New Contact Person (Overall Trial PI / Scientific / Public Query)/Site PI
- Indicate the new contact person and mark a copy of the mail to the concerned individual.
- Request a confirmation email from the new contact person acknowledging responsibility.
- Share this confirmation email(ctri@gov.in) with CTRI for unlocking.
- All this information needs to be in one mail only.
3. Modifications in Trial Details
This includes changes in:
- Intervention / Comparator Agent
- Inclusion & Exclusion Criteria
- Sample Size
- Scientific Title
- Primary and Secondary Outcomes/Any other field
Please follow the steps below for mail to CTRI(ctri@gov.in):
- Specify changes in a tabular format showing current and proposed information and the reason for change.
- Confirm whether EC/DCGI approval has been received (if applicable).
- Upload the relevant document in the EC section (permanently unlocked).
Sample Format for Submitting Changes:
| Field | Current Information | Proposed Update | Reason for Change |
|---|---|---|---|
| Sample Size | 100 | 150 | |
| Primary Outcome | Blood Pressure Reduction | Blood Pressure and Heart Rate Reduction |