CTMS stands for Clinical Trial Management System. It is computer software that is used by the various pharmaceutical industries to manage clinical trials in clinical research. Clinical trials are observations done in clinical research. The software contains, plans, performance, and report functions of individuals, along with their contact information, project timelines, and milestones. Clinical Trial Management Service serves as a centralized, web-based enterprise resource to support clinical research trials.
The purpose of Clinical trial management system software is to enable various clinical researchers to plan, track, and control all activities Related to the set-up, conduct, and closeout of a clinical trial. At the initial stage, the information isn’t much, so it can be stored using spreadsheets and tracked through emails but as the trials proceed to a greater extent it becomes necessary to adopt other tools to maintain those complex data efficiently. They require a more thorough and complete system that can not only manage the data, compliance, regulations, information about the patient, and project timelines but can also control the budgeting and financials And can coordinate with third-party systems that may have the company already in place.
A CTMS offers a secure, centralized space to store complex data acquired in clinical trials as it also enables the user to retrieve it. Patient information, study materials and can be easily accessible through a searchable database with just a click. Data reports and study reports can easily be added and quickly delivered to study teams, groups, and organizations; the system provides information in an organized and accessible manner. Through a centralized management system, one can observe and arrange the data management and analysis process.
A CTMS also helps In keeping track of various financial information related to a trial, ensuring accurate invoices for supporters and proper payment of each site. It also creates an interactive, detailed study calendar that enables it to track various Study-related costs, To ensure the revenue has been traced completely.
Over the world, hundreds of research facilities conduct many trials over the year, and a CTMS can also help in improving the overall efficiency within each trial. This easily accessible system helps researchers to focus more on their work instead of managing administrative work. Having a Centralised location for storing all the data reduces the need for duplicate data and researchers can easily look for missing data or they can make improvements to the prior data in a single software. A CTMS maintains the workflow of a clinical trial.
Validation for CTMS is a long process, having step by step requiring a large amount of documentation and process requiring multiple resources. Even a sudden change in data can take a long time, due to the long intensive nature of updates, companies have to continue running a changelog. This would allow the group to not make changes until the occurrence of a larger update, in that time they can also make changes to the little ones.
The CTMS should include an audit trail, to see the changes made in the information, implying who made them, why made them, and what changes have been updated.
Access to the CTMS must be given to the experienced person or providing necessary training to handle a CTMS, to individuals before giving them access to it. A list about who had access, when the access was granted and removed should be mentioned in it, to avoid complications.
The CTMS should include electronic Signatures for the records that apply to the regulatory conditions of the study. There are many documents involved in a study that needs to be signed, it causes inconveniences as it becomes hard to handle an internal document that must be signed on site. I.e. protocol signature pages or acknowledgments etc.
All CTMS must comply with the act of HIPAA and 21CFR Part 11(FDA). As a whole, the purpose of these Acts is to provide patients with full authorization over their Protected Health Information (PHI), such as the right to decide who can access them or use them.
HIPAA stands for Health Insurance Portability and Accountability. Whereas CFR stands for Codes of Federal Regulations. The HIPAA act was enacted in 1996 to regulate how Medical facilities collect, store, use and disclose an individual’s Health information, such as electronic health records. On the other hand, 21 CFR part 11 regulates the authenticity and confidentiality of electronic records used by clinical institutions.
Violation of these rules Is evaluated in 4 different tiers depending on the severity of the violation. They are,
Tier 1: where the individual was unaware of the violation or couldn’t avoid it. The penalty for this tier is a minimum fine of $100 per violation up to $50,000.
Tier 2: It is a situation where the individual must have been aware of the violation for its seriousness but he could not have avoided it, even with a reasonable amount of care. The penalty for this tier is a minimum fine of $1,000 per violation up to $50,000.
Tier 3: A violation caused for willful negligence of HIPAA rules. The penalty for this tier is a minimum fine of $10,000 per violation up to $50,000.
Tier 4: It is regarded as the most severe violation of willful negligence of HIPAA rules as well as No attempt to Rectify the violation. The minimum fine of this violation is $50,000 per violation.
Nowadays most of the CTMS is a cloud-based software as a service system. These systems are offered on the model of pay as you go. These systems are efficient for complex medical studies. Study reports, the Patient database can be easily stored in this system through any web-based device. Where all this information is stored in a secured central location that is maintained by a third-party service provider.
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