Table of Contents
Should all clinical trials be published?
Publication of Clinical Trial Results Other than early phase trials, sponsors of Clinical Trials of Investigational Medicinal Products (CTIMPs) should publish a research summary of their findings within one year of the study’s completion.
Do clinical trial results have to be published?
US law requires researchers to post study findings on a public registry within a year of completion — or face heavy fines. Many leading US universities are breaking the law by failing to make public the results of their clinical trials.
What trials need to be registered on clinical trials?
Which Trials Must Be Registered on ClinicalTrials.gov?
- The trial has one or more sites in the United States.
- The trial is conducted under an FDA investigational new drug application or investigational device exemption.
Why should trials be registered before they are conducted?
Why is trial registration Important? The registration of all interventional trials is considered to be a scientific, ethical and moral responsibility because: There is a need to ensure that decisions about health care are informed by all of the available evidence.
When should a clinical trial be registered?
Yes, you can register a study on ClinicalTrials.gov at any time. Please note that, in general, Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires Applicable Clinical Trials to be registered within 21 days of enrollment of the first participant.
What is clinical trial registration?
Trial registration creates a public record of all clinical trials that researchers are planning and what they intend to do, e.g. which intervention(s) they will be testing, the comparator(s) they will use, and what outcomes they will be measuring.
What is a registration Trial?
Registration Trial means the clinical trial activity required by a governmental regulatory authority to be completed as a prerequisite to the sale of a Product within the regulatory authority’s jurisdiction.
Why is registration important?
If you fail to register the property, the previous owner or the developer will be considered the legal and rightful owner. Legally, the sale of property won’t be considered valid till the sale deed is duly stamped and registered. The basic purpose of registration is to record the ownership of the flat.
What is a trial registration?
What is clinical trial registry?
The mission of the WHO International Clinical Trials Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making. This will improve research transparency and will ultimately strengthen the validity and value of the scientific evidence base.
What is a register in research?
Research registers may be regional, national or international registers of ongoing and completed research. They may record clinical trials as well as research conducted using other study designs.
What is the purpose of registration form?
A registration form is a list of fields that a user will input data into and submit to a company or individual. There are many reasons why you would want a person to fill out a registration form. Companies use registration forms to sign up customers for subscriptions, services, or other programs or plans.
Why should a document be registered?
Document must be registered to safeguard people from frauds, legal hurdles, and it can be used as valid evidence in court if it is required. In compulsory registration you cannot complete the transaction without registration of document.
Is it mandatory to register clinical trials with clinical trial registry of India?
It was initiated as a voluntary measure; however, registry was made mandatory by the Drug Controller General of India (DCGI) since June 15, 2009.
Why is it important to take a register?
The purpose of register is to better organize record keeping and ensure there is an efficient system for keeping and passing on information. It is a historical record and can be used for checking any information accurately at any instance of time. They facilitate continuity in the administration of a school.
Why is registration of documents important?
Since the documents are in the public domain, it helps prevent forgeries and fraud in transactions, especially the evasion of income tax, wealth tax or stamp duty. Besides, the cost of registering a document is not very high.
When should a document be registered?
WHEN TO REGISTER DOCUMENTS? According to Section 23 of The Registration Act, 1908, all documents except a will have to be presented for registration within 4 months from the date of execution.
Is clinical trial registration mandatory?
Although not mandatory, Sponsor‐Investigators of trials that do not meet the definition of an Applicable Clinical Trial are encouraged to submit the protocol and SAP to the primary register (ClinicalTrials.gov or ANZCTR, as applicable) as evidence of good clinical research practice.