Data Privacy and Confidentiality Discussion

Data Privacy and Confidentiality Discussion essay assignment

Data Privacy and Confidentiality Discussion essay assignment

Please respond

There are many clinical trial management systems (CTMS) used in clinical trials. Some are developed on site or at the organization specifically to meet the needs of the organization. Some are purchased off shelf and are used as is. Others offered by various vendors can be purchased and the vendor will customize the software to meet the needs of the organization. 21 CFR 11 outlines the requirements of electronic data systems. For this discussion you will take the role of a quality manager at a study site who has been tasked with evaluating CTMS products and recommending one for your site. Based on your review of 21 CFR 11, what are two (2) questions you would ask of a vendor about their CTMS to ensure it is compliant with 21 CFR 11? Why would you ask these two questions?

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Amanda

As a quality manager, there are many questions I would want to ask vendors regarding their clinical trial management system before recommending a product to our study site.  An important aspect during a clinical trial to subjects is privacy.  According to 21 CFR 11, there should be “adequate controls over the distribution of, access to, and use of documentation for the system operation and maintenance” (FDA, 2022).  My question for the vendor regarding this would be who has access to this data while doing any maintenance on this system?  I feel this is important because there should be the least amount of people possible looking at any patient information.  Although these employees working on the site are not aware of many healthcare terms and laws, the study site should have confirmation from the vendor that they are aware of Health Insurance Portability and Accountability Act (HIPAA) and have to sign a form stating this in case there is any sensitive information discovered.

Another concept that the study site is concerned with is getting a high-quality product to help us do our job more efficiently.   21 CFR 11 states that “determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks” (FDA, 2022).  A question I would ask the vendor would be what is the training process for your employees who help maintain the system?  This is an important question for the study site to make sure qualified individuals are working on this program.  We cannot use a faulty system that could possibly lose data or record it incorrectly. Although there are many questions to ask the vendor to confirm they are 21 CFR 11 compliant, I think experience and privacy are two topics that must be addressed.

FDA. (2022). CFR – Code of Federal Regulations Title 21. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs…

Kimberly

Assuming the vendor is providing an electronic documentation system that uses electronic signatures, as a quality manager evaluating the CTMS system, I would first ask how each documentation, verification, monitoring, and a pre-shipment signature will be guarded with a username type of blockage and a password? In other words, what keeps one person from trying to forge the signature of another or keeps everyone’s signature safe from tampering or falsification? 21 CFR 11.300 requires keeping up with all usernames (identification codes) and passwords to ensure security and integrity. All usernames and passwords are required to be unique, regularly maintained and revised, and managed in the event they are lost, stolen, missing, or the unemployment of the individual. This question would provide me with the knowledge that the system is secured and that I, and the company, could trust our electronic system was accurate and secured, not only for regulation purposes but for the protection and reliability of our products. (Controls for identification codes/passwords, 2017)

Another question I would pose for the electronic system vendor would be, “Is the system fully editable by all users with an identification code and password, or is the system able to limit certain accesses based on an assigned clearance level?” For example, verification and monitoring individuals should not be allowed to perform a pre-shipment review on a check they performed themselves. Obviously, they would sign off that their check was performed correctly. Those individuals should be overseen by another, more senior person to avoid conflicts of interest or falsification. Also, regulatory bodies must be able to view these records. It is possible they have their own username and passcode, but they should have no access to change records. Those individuals should only be allowed to view and not edit with their clearance. This question would provide me with a more suitable feel for how the system is handled based on clearance level and would allow me to make suggestions if different clearances were not warranted. It would be beneficial for my company, the vendor, and regulatory bodies to have a system that meets the needs of everyone who needs access while still upholding a high level of security for the documents.

Works Cited

Controls for identification codes/passwords., 21 CFR 11.300 (2017), https://www.ecfr.gov/current/title-21/chapter-I/su…

Justine

Question 1: 

Are biometric electronic signatures used in the Clinical Trial Management System (CTMS)?

This question is important because if the system is not based on biometrics, then controls must be implemented to ensure the identity of the user can be confirmed. According to the U.S. Food and Drug Administration (FDA), the profile must be used only by the owner of the account, and minimally there must be two unique identifiers such as a username and password. Biometric-based systems must be designed so that they cannot be used by anyone but the original owner (FDA, 2022). Knowing whether the system uses biometrics for identity verification will help in understanding applicable regulations for compliance

Question 2:

What controls are in place to ensure the security and integrity of electronic signatures?

Compliance with 21 CFR Part 11 means the system has controls that ensure electronic signatures are valid. Some controls include periodically requiring passwords to be revised or having a process to deactivate lost keys, passwords, or access codes to the system (FDA, 2022). It is essential to have a process that maintains access control to the system, especially if access is granted to more users thereby increasing the chances system access could be compromised.

References:

U.S. Food and Drug Administration. (2022, January 6). CFR – Code of Federal Regulations Title 21. accessdata.fda.gov. Retrieved April 19, 2022, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs…