Important Notice for all Trial Registrants

Retrospective Registration

From 1^st April 2018 onward, as intimated earlier, no new submission of any ongoing/closed to recruitment/completed trials will be feasible. However, due to the unprecedented number of such (ongoing/closed to recruitment/completed trial) submissions, the CTRI will process and register those trials which have been assigned REF number. Registrants are requested to proactively cooperate with CTRI when trials are sent back for clarifications/modifications and expedite trial verification..

The trials where queries/reminders and verification emails have been sent three or more times and responses from registrants are not received OR trials are resubmitted without any modifications will be deleted.

Trial related queries may be sent to ctri@gov.in quoting REF number in the subject line. If the trial does not have any REF number assigned, please note that the trial has not yet been submitted to the CTRI and will not be registered if the study has already begun enrolling patients.

Prospective Registration

Already submitted trials

Already submitted trials, where the first patient has not yet been enrolled but are pending with CTRI awaiting verification and/or submission of applicable approvals will not be deleted. However, registrants of these trials are requested to follow up proactively for any pending trial verification (especially incorrect email IDs) and ensure timely submission of applicable approvals (i.e. before the enrolment of any participant in the trial) to enable prospective trial registration of their trial.

Yet to be submitted trials

From 1^st April 2018, only those trials where the date of enrolment is a future date (please factor in a minimum of 10-15 working days for trial review/verification/validation) and the status is Not Yet Recruiting can be submitted.

Important note: While filling the online form for trial registration, Registrants are requested to pay attention to spelling punctuation word spacing and grammar. Only official address details, (department, hospital, institution, organization) should be provided. Personal residential/hostel addresses should not be mentioned. Please note that once a trial is registered all information is viewable globally and as uploaded.

Upon submission of a trial, the Registrant is advised to:

• Send an email to ctri@gov.in quoting REF number if there is no response within 7 working days of trial submission.

• Be prompt in addressing clarifications sought

• Expedite trial verification, a major cause for delay in trial registration.

For trial verification, an email is sent to all contact persons mentioned in the CTRI form (other than the Registrant) to the provided email ID confirm participation in trial. For a multi-site study, confirmation from even one site PI is adequate for registration, however individual confirmation from all other contact persons – Overall trial coordinator or PI, Contact person (scientific query) and Contact person (public query) is mandatory for trial registration. Hence, to avoid delay in trial verification, please ensure that:

• The correct, active and regularly accessed email ID has been provided.

• A single/uniform email ID has been used for an individual.

• The PI to whom the ethics approval is addressed features in at least one of the four possible contact persons (including site PI).

• In case of a PG thesis study, name of both Guide and Student, have been mentioned individually, at least once.

REF Number: Upon successful submission of a trial to CTRI, it is immediately assigned an REF number. If an REF number has not yet been allotted, please note that the trial has not yet been submitted to the CTRI and hence cannot be processed. To acquire an REF number, please go to Part 8 of the CTRI form and click on the "Submit trial to CTRI" button. Upon successful submission of trial, an REF number will be instantly assigned to trial which is to be quoted in all trial related correspondence.

Updating Registered Trials

After a trial is registered, it should be updated as per the current scenario and status of trial. Hence, automated reminder emails are sent every 6 months to all trial registrants to update their registered trials.

Important note: Any change/update in trial details of registered trials are captured and are freely viewable in the public domain in the Modifications link under any field that has been modified post-registration.

To update your registered trial in the CTRI, Login to CTRI and update the Status of trial (this field is permanently unlocked) – from not yet recruiting to open to recruitment and so on until status is completed.

Once trial is completed please fill in the two new additional data set items that appear and then send in a request quoting CTRI number in subject line to ctri@gov.in for field unlocking for further updates such as:

• Results in Brief Summary section

• Actual date of first enrolment in Date of First enrolment

• Publications arising out of the study in the Publication Details section

In case of any field unlocking during the course of the trial – due to typographical errors, protocol amendments, change in contact person details please follow as given below to avoid delay in field unlocking.

• Please send separate emails for each trial quoting CTRI number in subject line.

• Telephonic requests for field unlocking will not be entertained.

• Please allow for 5-7 working days for field unlocking of registered trials.

• Please follow the SOP provided below for a speedy action.

For site addition/deletion - Please upload EC approval of additional site/s under Ethics Approval section – this field is permanently unlocked. The Name of Ethics Committee should include name of PI for whom it is applicable. Please check for any mismatch of information as per current scenario regarding active/inactive sites and delete the inactive/unapproved proposed sites in the Ethics Approval section and upload any pending approvals for since approved sites.

Subsequently, send in an email to ctri@gov.in quoting CTRI number stating the desired action and that Ethics approval section has been appropriately updated. In case of regulatory trials, please forward DCGI approval/notification for site addition/deletion. Also include in the body of the email the list of sites and PIs that are to be added/deleted along with a column for EC approval status (e.g. uploaded for new site and no recruitment for site deletion etc.).

For inclusion of sites, which have not received EC approval, please mark a copy of the mail to the PI requesting a confirmation email regarding their participation in trial and forward DCGI approval for the same by email.

For new contact person (Overall trial PI/Scientific/public query): Please list new contact person mark a copy of the mail to new contact person and request email confirmation of responsibility.

For Intervention/comparator agent/ inclusion & exclusion criteria, sample size, scientific title primary and secondary outcome: Please specify changes (in a tabular format) and confirm that EC approval for the same has been uploaded and in case it is a regulatory trial, forward the DCGI approval as well.

For typographical errors: Please forward a tabulated list of before and after text with the changes highlighted. Unlocking of fields to update/modify future tense to present tense to past tense will not be entertained.

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