Easily Hide SNN Field in the Clinical Trial Agreement

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How to Hide SNN Field in the Clinical Trial Agreement

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Translator: Maira Cabrini Reviewer: Vanesa Gallego What Im about to tell you will shock you. It shocked me the first time I heard about it and frankly it still shocks me. When you go to a doctor and they prescribe you a medicine you presume its been tested and we know everything there is to know about whether it works, right? Well guess what. A lot of the time thats just not the case. And this is because around half of the clinical trials that have been carried out on medicines that we use today have never published results. So we dont know what was found out about our medicines in around half of the biggest trials that have happened on them. Clinical trials are those big tests where some people are given a new medicine and some other people are given a different medicine or no medicine at all to test whether the new medicine works and to see if its safe. The results from those trials are then used by governments who have to decide whether to pay for the medicine. By regulators, w

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Below are some common questions from our customers that may provide you with the answer you're looking for. If you can't find an answer to your question, please don't hesitate to reach out to us.

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Should clinical trial data be public?

Clinical trial transparency is important for patients, clinicians, researchers, clinical trial participants, and the public at large for numerous reasons. Sharing sensitive clinical trial data should always follow the guidelines laid out by regulatory authorities.

What is excluded from clinical trials?

Exclusion criteria specify characteristics that disqualify patients from participation and often include factors such as comorbidities or concomitant treatment or factors that could mask the effect of the intervention.

Is clinical trial data published?

The vast quantities of data collected throughout a clinical trial may result in several publications, depending on the scope of the paper, article, conference presentation, or other work.

Is clinical trial data subject to HIPAA?

For example, sponsored clinical trials conducted by a physician or at a hospital that submit data to the U.S. Food and Drug Administration may involve PHI and are therefore subject to HIPAA regulations.

What is the privacy rule in clinical trials?

The Privacy Rule is a response to public concern over potential abuses of the privacy of health information. The Privacy Rule establishes a category of health information, referred to as PHI, which may be used or disclosed to others only in certain circumstances or under certain conditions.

What is a Section 801 clinical trial?

Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) refers to a federal statute established in 2007 requiring the registration and reporting of information on applicable clinical trials on Clinicaltrials.gov.

How do you anonymize clinical trial data?

This allows for meaningful secondary analyses and follow-on research while maintaining patient confidentiality. Examples of anonymization include redacting the name, date of birth and other demographic identifiers of individuals associated with the conduct of the trial.

Is clinical trial data confidential?

Confidentiality in clinical research in the US is covered by the Privacy Rule that are a set of regulations provided by the department of health and human services (HSS) as a response to a congressional mandate in the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

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Hide SNN Field in the Clinical Trial Agreement