Uncontrolled Transparency

Posted by Thomas Wicks on May 23, 2017 1:19:28 PM


Operational Risks

Overview

Operational Risks is the possibility of issues arising from inadequate policies or procedures, poor data quality, insufficient systems, and human error.  Complying with the requirements of local and multi-national trial transparency regulations across the world requires the appropriate operational controls, training, and systems to manage the transparency processes reliable and efficiently.

For more information on the scope of global clinical trial disclosure, please refer to the previous post on Expanding Transparency.

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Topics: Clinical Trial Disclosure

8 Benefits for Clinical Trial Sponsors Using TrialScope's Trial Results Summaries Portal

Posted by Mark Mesterman on Mar 29, 2017 3:29:42 PM


INTRODUCTION:

Clinical Trial Sponsors are looking to provide Trial Results Summaries, also known as “Lay-Language Summaries” or “Plain-Language Summaries”.  TrialScope recently launched the Trial Results Summaries Portal at TrialSummaries.com to help sponsors meet their commitment to inform and educate trial participants and the general public about clinical trial results.  Providing summary information in an easily accessible web portal can help sponsors reduce distribution challenges and avoid privacy risks of direct mailing such summaries to participants.  The Trial Results Summaries Portal offers yet another way for sponsors to act on their commitment to transparency.

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Topics: Trial Results Summaries

6 Ways Patients Win with TrialScope's Trial Results Summaries Portal

Posted by Francine Lane on Mar 21, 2017 10:22:06 AM


INTRODUCTION:

Trial Results Summaries, also known as Lay-Language Summaries, or Plain-Language Summaries are documents that provide the results of a clinical trial in non-technical language that the general public can understand.  TrialScope has recently launched the Trial Results Summaries Portal to host these results with trial participants in mind.

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Topics: Trial Results Summaries

Benefits of the Trial Results Summaries Portal

Posted by Francine Lane on Feb 28, 2017 8:01:42 AM


INTRODUCTION:

If you saw our press release, you know we just released the Trial Results Summaries Portal. This solution represents a major shift in clinical trial transparency where we are connecting patients to trial results summaries in a more efficient and reliable manner.

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Topics: Clinical Trial Disclosure, Trial Results Summaries, Patient Engagement, Plain Language Summaries

The Final Rule Goes Into Effect

Posted by Francine Lane on Jan 19, 2017 9:40:55 AM


On Wednesday, January 18, 2017, the Final Rule for Clinical Trial Disclosure in the US went into effect.  But what is the Final Rule and what does it mean for study sponsors?

In September 2016, the United States Department of Health and Human Services (HHS) issued 42 CFR Part 11 for Clinical Trials Registration and Results Information Submission, commonly referred to as the “Final Rule”.  This Final Rule was a required update to Title VIII of the Food and Drug Administration Amendments Act (FDAAA) of 2007.  The Final Rule clarifies and completes requirements for registering clinical trials and disclosing clinical trial results.

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Topics: Clinical Trial Disclosure