Skip to main content

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.'


As per the upgraded version, EC-DCGI approval documents may now be uploaded from the CTRI site itself. The uploaded documents will not be visible in the public domain. It is now feasible to transfer a trial from one registrant to another, within a company or between companies. Besides, trials can be searched and viewed by using a single word search (keyword search) or specific field search (advanced search) or a layered search (trial search).

The Clinical Trial Registry of India was introduced by the government in July 2007 as part of its exercise to strictly regulate the clinical trial industry in the country. The National Institute of Medical Statistics (NIMS), an arm of the  Indian Council for Medical Research (ICMR) was mandated with the responsibility of setting up and maintaining the CTRI.

Based on the experience of the pilot project, it was decided to implement a fresh well designed Web Hosted Clinical Trial Registry to meet the expectations of the various stakeholders including the pharmaceutical industry, researchers, publications, administrators and the public at large. Being a front runner, among the first 10 across the world, in the implementation of the mandate of registration of clinical trials, the Clinical Trial Registry of India is being keenly monitored across the world.
Source: Pharmabiz 
Vidya Sury


Comments

Popular posts from this blog

Isotretinoin in India: A tragedy in the offing

Isotretinoin in India: A tragedy in the offing
Wednesday, March 28, 2007 08:00 IST 
Seema Thakral

Isotretinoin is the drug of choice for severe calcitrant cystic acne vulgaris, which often causes scarring and depression from disfigurement. Isotretinoin has been called "the greatest medical advance of the 1980's." A majority of patients with acne are permanently cleared after a four to five months course of treatment. It has also been used off-label for a variety of oncology uses including: cervical cancer, head and neck cancer, squamous cell cancer of the skin, juvenile chronic myelogenous leukemia (CML), and neuroblastoma. However, the drug is a proved teratogen and carries a significant risk of birth defects, if it taken during pregnancy. Birth defects, which have been documented following isotretinoin exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. There is an increased risk …

FDA Restricts Use of Diabetes Drug Avandia

FDA Decides Not to Ban Avandia, but Puts Restrictions on How It’s Used.
By Daniel J. DeNoon
WebMD Health News

Sept. 23, 2010 -- The FDA will not ban Avandia -- but stringent restrictions will make it far harder for doctors to prescribe the safety-troubled diabetes drug.

The European Medicines Agency took harsher action. European sales of Avandia-containing drugs will be suspended over the next few months, although the agency did not formally withdraw approval.

The 600,000 U.S. patients currently taking Avandia can continue to take the drug only if their doctors officially attest that their patients understand the risks, that the drug is helping them, and that no other diabetes drug can keep their blood sugar under control.

New Avandia prescriptions can only be written for patients who, for medical reasons, cannot take Actos. Actos, a diabetes medication in the same class as Avandia, does not cause the heart problems linked to Avandia.

"Avandia will be available to new pat…

The Connection Between Sedatives and Fractures in Elderly Patients

Johns Hopkins Health Alerts:
Prescription Drugs
The Connection Between Sedatives and
Fractures in Elderly Patients
All drugs have potential side effects. Indeed, at some point you've probably squinted down the laundry list of possible side effects on the package insert of your medications. Common drug-related side effects include blurred vision, drowsiness, dizziness, dry mouth, heart palpitations, erectile dysfunction, memory impairment, and nervousness. Fortunately, many of these drug side effects occur in only small numbers of people. Now researchers have called into question the connection between sedatives which can cause dizziness and the potential for falls in elderly patients. They point out that well-meant policies discouraging sedative use in older people to prevent falls and fractures may not be necessary. Starting in 1989, New York State required doctors to fill out prescriptions in triplicate for benzodiazepines, the most widely used class of sedatives. Tw…