The CTMS program continues to move forward with the hard work of the team. Here’s an update with where we are at as of July 2020:
As the CTMS is a ‘Provincial’ Program, a leadership team has been formed with representation from all participating organizations. This team will drive provincial alignment and enable and support change within their teams.
Northern Health is the newest group to join our program. Welcome to Julia Bickford and her team! They will likely be part of round 2 implementations.
Here’s the new updated program org. chart.
Program Vision, Objectives, Success
The Leadership team worked together to provide clarity around a vision and objectives – the vision may need some wording modifications and the objective measures further refined, but they are as follows:
“Clinical trials management in BC: Improved. Efficient. Collaborative. Informed.”
Program success is defined as follows:
Achieved if the objectives are met and benefits realized. Additionally, Research teams are using a common tool with ease and view it as a valuable resource. Improved efficiency in the administrative processes. Organizations can properly capture and collect revenues. Real time access to information on clinical trial activity is available.
Another task for the leadership team was to further define our scope:
Types of trials
All sponsored and investigator led clinical trials in BC that are publicly registered are currently in scope for the CTMS program.
Out of scope – Research only trials are out of scope.
All processes relating to the CTMS tool are in scope.
Out of scope – Clinical trial management processes not directly tied into the CTMS tool – eg. Institutional approval process.
Health Authorities are in scope as initial participants of the program.
Out of scope – Non-Health Authority affiliated are not in scope, but may be at a further date.
Out of the box CTMS from Realtime, some add-ons are optional – text, pay
Out of scope – Additional Realtime add-ons are not currenlty in scope – eSource, mobile
Below is our high-level approach for the program and where we are at. A program charter is underway – this will help guide the program and subsequent implementations.
Current State assessments
Making CTMS improvements begins with an assessment of the current state to gain an understanding of the following:
- Current clinical trial management processes, tools, roles, and challenges
- Alignment and gaps of clinical trial processes within and across BC’s Health Authorities
- Scope of change required and how RealTime’s CTMS platform will fit in
Workshops were held with one or more research programs from each Health Authority
- The entire lifecycle of a clinical trial was reviewed with a focus on key activities, roles, tools, and issues with managing industry and investigator led trials
- Workshop participants were asked to provide copies of existing tools (XL files, folder structure on network drive, templates)
- Each group was provided with a set of current state process maps to review and provide additional feedback
A current state assessment report is complete and is currently with members of the program team for feedback. This work will be used as a baseline, to guide building our future state, and the CTMS training program. Below is a Clinical trial lifecycle, one of the outcomes of the work.
Clinical trial lifecycle
As vendor and participation agreements are still in progress, our implementation schedule (first round) has been pushed out to August/September.
We will be designing processes around the Realtime CTMS platform and making minor technology adjustments (configuration).
After the technology and processes are ready, we will start to perform testing and prepare for training.
Thank you for your continued support and special thanks to the program team for their hard work and dedication to the program.