What is follow up period in clinical trial?

Monitoring a person’s health over time after treatment. This includes keeping track of the health of people who participate in a clinical study or clinical trial for a period of time, both during the study and after the study ends.

When should I update my ClinicalTrials government?

Required Registration Updates Other changes or updates to the record, such as protocol amendments, must be made at least every 12 months. It is recommended that the Record Verification Date be updated at least every 6 months for studies that are not yet completed, even if there were no changes to the record.

How far back does ClinicalTrials.gov go?

The ClinicalTrials.gov results database was launched in September 2008 to implement Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (PDF), which requires the submission of “basic results” for certain clinical trials, generally no later than 1 year after their Completion Date (see Primary …

What is the normal time for clinical trials?

six to seven years
Clinical trials alone take six to seven years on average to complete. Before a potential treatment reaches the clinical trial stage, scientists research ideas in what is called the discovery phase. This step can take from three to six years.

Why is follow up care important?

First, follow-up care generally keeps patients healthier and drives positive care outcomes. Second, early follow-up care can help reduce hospital readmissions. Regular post-discharge check-ins help catch complications early and mitigate growing issues, thus keeping patients out of the hospital.

Do all clinical trials have to be registered?

The International committee of medical journal editors requires registration of trial methodology, but does not require registration of trial results; however, the U.S. Food and Drug Administration Amendments does require researchers to register results.

Who is responsible for registering a clinical trial?

Who Is Responsible for Registering Trials and Submitting Results? The responsible party for an applicable clinical trial (ACT) must register the trial and submit results information. The responsible party is defined as: The sponsor of the clinical trial, as defined in 21 CFR 50.3; or.

Can you be forced into a clinical trial?

Participating in clinical trials is voluntary. You have the right not to participate, or to end your participation in the clinical trial at any time. Read the informed consent document carefully.

What are the fundamentals of clinical trial follow-up?

Research fundamentals: follow-up of subjects in clinical trials: addressing subject attrition Many published clinical trials have less than adequate follow-up. When conducting a clinical trial, researchers attempt to minimize data loss; however, some data may not be collected, particularly when subjects are lost to follow-up.

Is there a follow up period for research?

Defining a follow-up period is important to the research protocol (even if the follow-up period is “until progression” or “until death”).

How to avoid data loss in clinical trials?

When conducting a clinical trial, researchers attempt to minimize data loss; however, some data may not be collected, particularly when subjects are lost to follow-up. Careful planning of research protocols, including comprehensive in … Many published clinical trials have less than adequate follow-up.

How long do you have to follow up on an adverse event?

EXAMPLE: Subjects will be followed for toxicity for 30 days after treatment has been discontinued or until death, whichever occurs first. The clinical course of each adverse event will be followed until resolution, stabilization, or until it has been determined that the study treatment or participation is not the cause.

What are the long term follow up guidelines for human gene therapy?

17 We, FDA, are providing you, 1a sponsor who is developing a human gene therapy (GT) product, 18 recommendations regarding the design of long term follow-up observational studies (LTFU 19 observations) for the collection of data on delayed adverse events following administration of a 20 GT product.

Defining a follow-up period is important to the research protocol (even if the follow-up period is “until progression” or “until death”).

What is the long term follow up period?

25 which is commonly referred to as the “long term follow-up” (LTFU) period (of a clinical study). 26 LTFU observations are extended assessments that continue some of the scheduled observations 27 of a clinical trial past the active follow-up period, and are an integral portion of the study of 28 some investigational GT products.