Managing Clinical Trial Agreements

A Clinical Trial Agreement (CTA) as defined in The Malaysian Guideline for Good Clinical Practice is “a written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract.”¹

Review and negotiation of a CTA is an important process as it affects the trial activities conducted at site since the study or trial could not commence without any CTA in place. In 2015, the Clinical Research Malaysia (CRM) Legal & Regulatory Affairs Department developed its Clinical Trial Agreement System (CTA System) to provide a systematic and efficient way to review, as well as speed up the CTA process. This CTA System is an online platform where all the CTA(s) for the Malaysian Ministry of Health sites are submitted by sponsors and CROs.

The CTA System was launched in March 2016 and since then, all the negotiation, review, approval, and endorsement of the CTA are conducted via the CTA System, which features automatic alerts to CRM Legal to review. The total number of CTAs that have been reviewed via CTA System is illustrated below featuring a total of 562. Currently, there are 180 sponsors, 49 CROs who are registered under the CTA system, who are in charge of negotiating the CTA terms and conditions, as well as the study budget with the site.

System benefits

Sponsors and CROs can keep track of CTA status from the day of study registration until completion. The system offers transparency of the collaboration of work between the sponsor/CROs and CRM’s Legal & Finance department as all the correspondences and communication are held within the system.

The CTA System enables the CRM Legal & Regulatory Affairs department to keep track of studies by accessing ‘New’ & ‘Review’ tabs for the studies which are still in the reviewing process, and the ‘Settled’ tab for the studies which have been endorsed by the reviewer. Registered users can also transfer and handover a specific study from a previously registered clinical research assistant to the new appointed clinical research assistant, which provides a seamless flow of information. This assignment and changes of the study is still subject to the approval of the registered user of the study in the CTA System. Another alert feature prompts a notification via-email when a user has given a comment in the platform, allowing all parties to be aware of changes or a need to act.

Prior to the system’s implementation, from 2012 to 2015, the CRM Legal & Regulatory Affairs department took an average of 59 days to review CTA until endorsement.² Since the system’s implementation, CTA review has been expedited only 14 days.

Data management security

When there are any activities that involve data interchange, secure data management should be a top priority. With CTA System authentication and encryption methods, a secure data management protects parties involved in the CTA negotiation from data losses, thefts, and breaches. Strong data security ensures that critical CRM and clinical research assistant data is backed up daily and retrievable in the event that the primary source fails. The CTA system provides a safe, centralized site for data collection and storage, as the clinical research assistant provides some confidential data in the CTA system for the purpose of CTA review, such as the study protocol, study budget, and so on. All data entered into the CTA system is backed up in the backup system, which serves as a risk mitigation measure in the event of a system failure. Apart from the foregoing, the CTA system has a function that allows the study CTA information to be quickly retrieved. The CRA can find any previous CTA submissions by searching the Protocol ID or NMRR ID of the study. The same applies to CRM Legal.

In fact, CRM has gone a step further in terms of CTA review by recognizing the CTA system as a single source of operational truth, allowing all audit processes to run smoothly because all communication and data are saved and stored in proper tabs with specified dates and times. In addition, the essential data in the CTA system can be collected and organized at the corporate level through CRM Legal and Finance as departments to better track CRM's key performance indicator.

To conclude, CRM’s investment into an efficient and well-ordered collaborative Clinical Trial Agreement System serves to encourage sponsors and CROs to do more clinical trials in Malaysia.

Siti Nuralis binti Abd Muis is a Legal Executive; Heidi Nai Soraya Roslan is a Legal Assistant; and Nurul Atiqah Binti Abd Rahman is a Senior Legal Executive of Clinical Research Malaysia

References

1. National Pharmaceutical Regulatory Agency (NPRA) Ministry of Health Malaysia. Malaysian Guideline for Good Clinical Practice (Fourth Edition). Glossary 1.21. pg 10. 2018.
2. https://clinicalresearch.my/evolution-of-clinical-trial-agreement/