What is a registrational trial?

The Source : What is a registrational trial?

You are learning about: “What is a registrational trial?”. This is a “hot” question with 2,590,000,000 searches/month. Let’s fleetserviceshocrv.com learn more about What is a registrational trial? in this article.


Registrational Trial means a Clinical Trial that is designed to obtain sufficient data and results to support the filing of an application for Regulatory Approval (but may not include the data that may be necessary to support the pricing and/or reimbursement approvals ).

What is a registrational clinical trial?

Registrational Trial means a Clinical Trial that is designed to obtain sufficient data and results to support the filing of an application for Regulatory Approval (but may not include the data that may be necessary to support the pricing and/or reimbursement approvals).

When does a converted trial become a registrational trial?

For clarity, a Converted Trial shall only constitute a Registrational Trial for purposes of this Agreement from and after the Conversion Date with respect to such Converted Trial.

What is a trial registration number (trial registration number)?

You should include the trial registration number (also known as a clinical trial number) in the abstract of any manuscripts that report the results of that clinical trial. Trial registration makes the research process more transparent.

What are the benefits of trial registration?

Trial registration makes the research process more transparent. Registering clinical trials helps make sure that researchers try to publish all research that is carried out, even if the outcome was non-significant or ‘negative’.


Understanding Clinical Trials


More about What is a registrational trial?


1. Registrational Trial Definition | Law Insider

Registrational Trial means a controlled or uncontrolled human Clinical Trial of a Licensed Product that is intended (as of the time the first patient is enrolled in the Clinical Trial) to obtain sufficient data and results to support the filing of an application for Regulatory Approval without the requirement for any further Clinical Trial prior to submission of such …

From www.lawinsider.com

2. Registrational Clinical Trial Definition | Law Insider

Registrational Clinical Trial means a Clinical Trial of a Licensed Compound or Licensed Product for a particular indication where the data and results generated from such Clinical Trial are reasonably expected to be sufficient to, and reasonably intended to, support the filing of a NDA/MAA to obtain Marketing Authorization to market and sell that Licensed Product in the …

From www.lawinsider.com

3. registrational trial fda Online – New / Renewal. Fully Online Process …

Jan 06, 2020 · An registrational trial fda FEI number is a unique identifier issued by US FDA to track inspections of the regulated establishment or facility. registrational trial fda number are also used to track GDUFA facility fee payments.

From efundbook.com

4. FDA REGISTRATION TRIALS: A DATA MANAGEMENT …

What is a registration trial? A trial that is branded “registration” means that it is planned to move forward for review by the FDA as either a new agent, or to expand the labeling for new indications Currently enrolling SWOG registration trials: S1400 & sub-studies S1400G, S1400I (Lung-MAP) S1404 (Melanoma) S1418 (Breast) S1605 (GU)

From www.swog.org

5. Trial registration – WHO

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 It is difficult to make informed decisions if publication bias and selective reporting are present

From www.who.int

6. Trial registration – BioMed Central

Trial registration 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.

From www.biomedcentral.com

7. Clinical Trials Registration and Informed Consent Posting

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health related biomedical or behavioral outcomes.

From research.wustl.edu

8. The Importance of Differentiating Between Registry Study and …

Oct 31, 2017 · Well-designed research protocols that clearly differentiate between a registry study and interventional trial can cut down on review time, minimize questions from an institutional review board (IRB), and better ensure compliance and subject protection. Differentiating registry studies and interventional trials is required to protect research participants, and is essential to …

From acrpnet.org

9. Progress And Pitfalls In Getting Clinicians The Trials That They …

Registrational Trials: Necessary, Not Sufficient Strategy Trials: Giving the people what they want Clinical Networks: Improve US Site Enrollment in both

From www.fda.gov

10. Pivotal Clinical Trials: Frequently Asked Questions – Sofpromed

Jan 07, 2020 · Pivotal clinical trials (also known as “registration studies”) are very important because their results will be evaluated by regulatory authorities to decide whether or not a drug shows the safety and efficacy required to be approved and commercialized. What is the main general goal of a pivotal clinical trial?

From www.sofpromed.com


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