How Long Does It Take To Register A Trial

CLINICAL TRIALS REGISTRY - INDIA, NATIONAL INSTITUTE OF MEDICAL STATISTICS, ICMR

Often Asked Questions:

What is the Clinical Trials Registry - Republic of india?

What is a Primary Registry?

I am a patient of bronchial asthma and would like to participate in a clinical trial exploring new treatment options. How can I search for such a trial?

Who is responsible for registering a trial?

Why should trials be registered in the CTRI?

My trial is already registered in another Primary Register, then why exercise I need to register again with the CTRI?

But if the same trial is registered in two or more registries won't it be counted as separate trials?

Is it mandatory to register my purely observational study?

What blazon of clinical studies are registered in the CTRI?

What trial related data are collected in the CTRI?

Is the trial registration dataset different for the different types of clinical studies?

What documents, if whatever, are required to be submitted for study registration?

Where practise these documents have to be submitted?

Are at that place any fees for registering a trial in the CTRI?

How long does it accept for a study to be registered?

When should a clinical study be registered?

I am doing a retrospective data collection study and I have begun the report. Can it still be registered?

What is the process of registering a trial with CTRI?

I have submitted my trial over a month agone but there has been no response till now?

Where can I locate my REF number?

What does it mean if both REF and CTRI number are indicated equally 'Awaiting'?

How tin can I acquire an REF number for my trial?

I clicked on the SUBMIT TRIAL TO CTRI button but the form failed to be submitted even though I filled all the field. What should I practice?

How tin I discover the health condition that is best suited for my study?

Now that I accept an REF number can I begin enrolling patients in the trial?

I uploaded my trial before enrolment of the first patient merely started the trial as I was not enlightened about the REF and CTRI numbers. Can my trial be registered now?

From where tin I obtain a certificate confirming the registration of my trial?

I tin can view my trial in the public domain at CTRI just not in the WHO search portal?

Even though my trial has been assigned a CTRI number, it is non searchable from Google?

What is the process for deleting my registered trial from the CTRI?

Tin can I brand changes in the trial details after it is registered?

What if I accept some queries or concerns that are non addressed here?

What is the Clinical Trials Registry - Republic of india?

The Clinical Trials Registry - India (CTRI) launched on 20^th July 2007 is managed by the ICMR-National Found of Medical Statistics, New Delhi, India. The CTRI ( world wide web.ctri.nic.in) is an online, gratuitous and searchable system for the prospective registration of all clinical studies being conducted in India. In add-on, the CTRI besides registers clinical studies existence conducted in countries which practise not have a Principal Registry of their own.

What is a Primary Registry?

The WHO has prepare a Registry Network wherein clinical trial registries with specific criteria for quality content validity accessibility etc. are designated as Primary Registries. There are currently 17 Primary Registries of the WHO, including the CTRI.Hence data of CTRI is also searchable from the WHO'due south International Clinical Trials Registry Platform (ICTRP). The ICTRP search portal ( http://apps.who.int/trialsearch/) provides a single point of admission to trials registered across its network of registries. The US registry, i.due east. ClinicalTrials.gov although the largest data provider to the ICTRP it is not a Master Registry of the WHO.

I am a patient of bronchial asthma and would like to participate in a clinical trial exploring new handling options. How tin can I search for such a trial?

Registered trials can be searched by using appropriate keywords (such as bronchial asthma) in the search box on the CTRI abode page. Once the list of trials are displayed, the trial titles may exist screened for shortlisting and details viewed for deciding possible feasibility of participating in a particular trial, given the status of trial (not yet recruiting or open to recruitment) also equally inclusion and exclusion criteria. For whatsoever help in this regard, an e-mail may as well be sent to ctri@gov.in.

Who is responsible for registering a trial?

A responsible Registrant, Trialist or User is authorized to register clinical trials in the CTRI. Registration in the CTRI is needed to gain access to this facility. The "Registrant" for a trial is either the master investigator (PI) or the primary sponsor, to exist decided by an agreement between the parties. The principal sponsor is ultimately accountable for ensuring that the trial is properly registered. For multi-center and multi-sponsor trials, it is the lead PI or lead sponsor who should accept responsibility for registration.

Why should trials be registered in the CTRI?

Registration of all regulatory clinical trials is mandatory as per the drug licensing authority in India i.due east. the Drugs Controller Full general (India) (DCGI). In addition, several journal editors, ethics committees and medical colleges have made information technology mandatory to annals clinical studies in the CTRI.

My trial is already registered in another Master Annals, and then why do I need to annals again with the CTRI?

A clinical trial being conducted in Bharat, is also required to be registered in the CTRI equally the CTRI captures data specific for the Indian arm of a trial, e.g. Site and PI details, Name of Ethics Committee and approval condition, target sample size in India, start date in India etc.

But if the same trial is registered in 2 or more than registries won't it be counted as dissever trials?

To ensure that trials registered in multiple registries are publicly identified as a unmarried trial, Registrants must quote the Registration number of the other Primary Registry number or Partner Registry number (ClinicalTrials.gov number) in the Secondary ID section of the CTRI trial registration data. This helps the trial to exist identified as a single trial, despite beingness registered in 2 or more than registries.

Is it mandatory to register my purely observational study?

The CTRI is a facilitator body that provides a platform for registering clinical studies equally mandated past the drug licensing authorisation, ethics committees and journal editors. Further, the WHO advises 'When in incertitude, annals'.

In addition, it may be noted that since 1^stApr 2018, the CTRI merely registers clinical trials prospectively, i.eastward., before the enrolment of the first patient and hence the decision to annals should be made earlier trial initiation as registration volition not be feasible afterward.

What type of clinical studies are registered in the CTRI?

All types of clinical studies, i.e. interventional, observational, bioavailability/bioequivalence and post-marketing studies are registered in the CTRI. In addition it may exist noted that clinical studies from traditional medicinal systems besides as clinicalstudies conducted as part of post-graduate thesis are also registered in the CTRI.

What trial related information are nerveless in the CTRI?

The following data is recorded in the CTRI:

Public championship of study

Scientific Championship of Report (Trial Acronym, if whatever)

Secondary IDs

Principal Investigator'south Proper name and Address

Contact Person (Scientific Query)

Contact Person (Public Query)

Sources of monetary or textile back up

Main Sponsor

Secondary Sponsor

Countries of Recruitment

Site/s of study

Proper noun of Ethics Committee and approval condition

Regulatory Clearance obtained from DCGI

Wellness Status/Trouble studied

Intervention and Comparator amanuensis

Primal inclusion/Exclusion Criteria

Method of generating randomization sequence

Method of allocation concealment

Blinding and masking

Principal Outcome/southward

Secondary Outcome/s

Status of Trial

Phase of Trial

Written report Blazon

Date of first enrolment

Estimated duration of trial

Target sample size

Brief Summary

Date of actual study completion

Final enrolment number achieved

For detailed information and explanation of each field click on [ Trial Registration Information Gear up] on the CTRI Home Page.

Is the trial registration dataset different for the different types of clinical studies?

Currently the trial registration information set is same for all types of clinical studies.

What documents, if whatever, are required to be submitted for study registration?

Submission/upload of ethics approving is mandatory for registration. In addition, submission of approval from the DCGI, wherever applicative, is also mandatory. In improver, electronic mail verification/confirmation of participation in trial by trial contact persons, i.e. overall trial PI, contact person Scientific query, Public query, Site PI (from the email ID provided in the CTRI course) is also mandatory.

Where do these documents have to be submitted?

Equally the CTRI is a paperless organization, submissions are all online and these documents are to be uploaded into the system while filling the CTRI form. Verification is by email wherein trial designated Contact Person/s is/are expected to respond to the email sent by CTRI ( ctri@gov.in).

Are there whatsoever fees for registering a trial in the CTRI?

No, at that place areno fees for registering trials in the CTRI

How long does it have for a study to be registered?

Upon submission of a report to the CTRI, information technology is reviewed inside 7 to ten working days and sent dorsum to registrant for clarifications/modifications. In addition, verification emails are sent to trial participants. Further action can only be taken by CTRI when the trial is resubmitted to the CTRI. Hence the time taken for trial registration is heavily dependent on the response of the registrant. The sooner the modifications are incorporated, approvals uploaded, verification received and trial resubmitted, the faster is the registration.

When should a clinical study be registered?

A clinical written report should be registered prospectively i.eastward. earlier the enrolment of the starting time patient into the study.

I am doing a retrospective data collection study and I have begun the report. Can it still be registered?

No. Even retrospective information collection studies should be registered before the initiating information drove.

What is the process of registering a trial with CTRI?

To register clinical trials, Registrants must kickoff register as users (obtain username and countersign). The username and countersign may exist obtained by accessing the Home Page of the CTRI (www.ctri.nic.in) and filling the NEW USER form online and submitting it online. A confirmatory mail with username and password will exist sent to the email ID provided. However this will be activated only upon receipt of a second confirmatory postal service.Please login to CTRI and upload trial data by clicking on "Add together NEW TRIAL", and filling requisite data fix form that appears. Delight notation that the course has to exist filled online only and may be filled in parts at your convenience. For the trial to be available to CTRIfor review, please click on the Submit button that appears in the last section, i.e. Part 8 under the Brief Summary section to send the trial to CTRI for review.

I have submitted my trial over a month ago but there has been no response till at present?

In such a situation please send an email to ctri@gov.in quoting your REF number.

Where can I locate my REF number?

Please login to your account in the CTRI and on your Welcome Page, the REF number would be mentioned alongside the trial title.

What does it mean if both REF and CTRI number are indicated as 'Pending'?

If REF number is pending this indicates that the trial has not yet been submitted to the CTRI for processing.If CTRI number is pending this indicates that the trial has not yet been registered.

How tin I acquire an REF number for my trial?

To learn an REF number, please make full all parts of the CTRI form and then click on the SUBMIT TRIAL TO CTRI push button nowadays under the Brief Summary section in Part 8. If all mandatory fields have been filled, the trial will be instantly be assigned an REF number will be displayed on your screen.

I clicked on the SUBMIT TRIAL TO CTRI push button but the form failed to be submitted even though I filled all the field. What should I do?

In example of a tabulated list with cross marks please click on the link against which there is a cross mark and make full the relevant field such every bit Sources of Budgetary and Material Back up. Please annotation that this field is distinct from the Main Sponsor field and should be filled by clicking on the Add NEW button. In example of any other concerns please send a screenshot to ctri@gov.in

How can I find the health condition that is best suited for my written report?

Please choose category of trial participant, healthy human volunteers or patients. One time Patients is selected, the ICD-10 coded drop down list provided upwardly to a maximum of four levels of disease categories.. Sometimes the relevant disease category maybe available in the third or fourth category. For instance for dental trials, cull Diseases of digestive organisation (K series) so Diseases of Oral crenel and salivary glands and at the 3rd level the appropriate disease nomenclature for your study. Similarly for Surgical/anaesthesia trials, the appropriate health condition would be available under (PCS) ICD 10 Procedure Coding Arrangement Codes.In case of any queries, delight send an email to ctri@gov.in

At present that I have an REF number can I brainstorm enrolling patients in the trial?

No. Assignment of an REF number only indicates that the trial has been submitted to the CTRI for review. A trial is considered registered in one case it has been assigned a CTRI number. Farther, since the CTRI only registers studies prospectively, if patient enrolment is initiated before it is registered (i.eastward. assigned a CTRI number) the trial will not exist registered fifty-fifty if it has been assigned an REF number.

I uploaded my trial before enrolment of the first patient just started the trial every bit I was non aware about the REF and CTRI numbers. Can my trial be registered now?

No, the trial cannot be registered as only prospective registration is undertaken by the CTRI, i.due east. registration earlier the enrolment of the first patient into the study.

From where can I obtain a document confirming the registration of my trial?

No document is issued upon registration of a trial. The CTRI number may be quoted wherever required as the registered trial would be viewable and searchable in the public domain ( www.ctri.nic.in). Further a PDF copy of the registered trial may exist generated by clicking on the link above the trial details and submitting the same to the advisable dominance.

I tin view my trial in the public domain at CTRI but not in the WHO search portal?

Upon trial registration trials are immediately viewable in the public domain from the CTRI. However, registered trial data are shared and uploaded at the ICTRP every month.

Even though my trial has been assigned a CTRI number, it is not searchable from Google?

Once a trial is registered with the CTRI, it may be viewed in the public domain by using relevant trial keywords (or the CTRI number) in the Keyword search box or avant-garde search options on the CTRI Dwelling house Page. Trials registered in the CTRI are besides freely searchable from the WHO's search portal ICTRP or the International Clinical Trials Registry Platform ( http://apps.who.int/trialsearch/). While the CTRI database is searchable from other online search engines such as Google, still, this is not in the domain of CTRI.

What is the procedure for deleting my registered trial from the CTRI?
In one case a trial is registered in the CTRI it cannot be deleted. However, if the trial is non conducted for some reason, the status of trial should exist changed to Terminated and reason cited in the Brief Summary department. Suspended trials also demand to follow the aforementioned process

Can I make changes in the trial details after it is registered?

To brand changes in a registered trial, delight follow the SOP detailed beneath:

For site addition/deletion- Please upload EC approval of boosted site or site deletion under Ethics Approval - this field is permanently unlocked and revert by postal service for site unlocking. Delight also forward the listing of new site/southward and PI/s in the postal service addressed to ctri@gov.inquoting the Reference Number in the discipline line. For those sites which accept not received EC approval, delight mark a copy of the mail to the PI requesting a confirmation email to this email ID regarding their participation in trial.

For new contact person (Overall trial PI/Scientific/public query)- Please indicate new person, mark a copy of the mail service to concerned person and request mail confirmation of responsibleness quoting the Reference Number in the subject line.

For Interventional/Comparator agent/ inclusion & exclusion criteria, sample size, scientific title chief and secondary upshot, please specify changes (in a tabular format) mentioning the name of the section to be unlocked, previous information, nowadays information and reason for change and ostend thatEC approval has been received for the amendments, if applicable, and upload in EC section which is permanently unlocked

What if I have some queries or concerns that are non addressed here?

In example of whatsoever other queries or concerns please ship an email to ctri@gov.in quoting REF or CTRI number in the subject line, wherever applicative. You may also view the e-tutorial for CTRI bachelor at http://ctri.icmr.org.in/

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