Hide Data in the Clinical Trial Agreement

Aug 6th, 2022
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How to Hide Data in the Clinical Trial Agreement

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um Im excited today to kick off the fall clinical trials toolkit series um our first one is the office of sponsored programs clinical trial agreement review and negotiation um today we have Rachel humberson she is the interim assistant director um from research office and office of sponsored programs and we also have um Julie even though I practiced it Julie Im going to mess it up Anna okay is that right yeah okay she is a negotiator with research with the research office and office of sponsored programs um before I read their um their bios and a fun fact about them again we are offering continuing education to WVU employees so if um you would like CES please indicate that and please put your name um an email address in the chat so for attendance purposes um Im trying to think if theres anything else oh if you have a question during this um feel free to put it in the chat well be watching it and um I will stop Rachel and Julie and let them know what your question is and then also

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Best practices for anonymising text Use pseudonyms or replacements that are consistent within the research team and throughout the project. For example, use the same pseudonyms in publications and follow-up research.
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.
Data anonymization is done by creating a mirror image of a database and implementing alteration strategies, such as character shuffling, encryption, term, or character substitution. For example, a value character may be replaced by a symbol such as * or x. It makes identification or reverse engineering difficult.
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.
Assign methods of anonymisation for direct identifiers Delete. For the TOPPIC trial, all names, initials, addresses (including email) relating to patients, relatives and study personnel were removed from the anonymised database. Modify.
The three missing data mechanisms are missing completely at random (MCAR), missing at random (MAR), and missing not at random (MNAR). MCAR means that missing values are randomly distributed over the data sample. The reason for missing data is not related to relevant study variables or outcomes.
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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