Clinical Research Coordinator Level 1 Programme (March 2024 intake)
Programme Duration: 1 March to 19 April 2024
Venue: NTU@one-north
Organiser: SCRI Academy
The CRC Level 1 Programme is a comprehensive introduction to how clinical trials are run. The course is tailored for junior clinical research coordinators (with at least one year experience) and provide practical training involving real-world case studies and hands-on application of skills through role-play.
In March 2024, SCRI Academy welcomed 36 junior CRCs to the 12th cohort of the CRC Level 1 Programme.
Participants from the CRC Level 1 Programme, March 2024 intake
The seven-week programme offered a strong foundation for participants to effectively carry out their duties as a CRCs in public healthcare institutions such as hospitals and polyclinics.
The programme kicked off with a Bingo ice-breaker game for participants from various public healthcare institutions to get to know one another.
Thereafter, lessons began proper, and the junior CRCs were introduced to the range of clinical trial activities from study initiation to closure. They also discussed the importance of Good Clinical Practice (GCP), understanding their responsibilities in supporting Principal Investigators (PIs), and guidelines to follow when it comes to research reporting.
For hands-on skills, they practised the steps in gaining informed consent from trial participants, as well learnt useful tips on how to maintain research documents, as well as how to collect quality data and fundamentals of data entry.
The regulatory requirements and guideline protocols for clinical trials conducted in Singapore were also taught during the programme.
Participants were invited to ask questions and queries raised were swiftly clarified during the programme. Read on below for useful tips for junior CRCs:
Do I need to start a new delegation log when there is a change in PI?
Answer: Yes. The CRC must close the delegation log for the previous PI by entering the end date (i.e. the date of study handover). Following this, a new delegation log should be created for the new PI, re-delegating the study team members with a start date that begins immediately after the end date of the previous PI.
After the amended protocol version has been approved by IRB and regulatory authorities, can the study team discard the previous version to save storage space?
Answer: No, all versions of the documents should be retained in the investigator site file and archived in accordance with the institution’s policy.
What is the difference between pre-screening and screening when considering potential trial participants for clinical trials?
Answer: Pre-screening is a preliminary step that does not entail any study procedures. It aims to identify potential participants whom doctors or investigators can approach to find out if they are keen to join the study. If a potential participant expresses interest, the investigators will seek their consent before proceeding with screening activities, which may include lab tests, physical examinations, and data collection.
The course was taught by an experienced team of trainers from both the public and private sector organisations from the clinical research industry. They drew from their vast experience in clinical trials and provided the participants with actionable tips on how to overcome challenges faced in the course of their work.
SCRI Academy would like to extend our heartfelt gratitude to all training partners – Nanyang Polytechnic, Health Sciences Authority, Labcorp Drug Development Pte Ltd. and Ms Michellore Aguillar from the SingHealth Investigational Medicine Unit – for their unwavering support throughout the programme.
Heartfelt thanks to all training partners
By the end of the course, participants shared that they found the group discussions and role-play activities provided good opportunities for them to practise their newfound skills. They also gained a better understanding of the job responsibilities of a CRC and felt more assured that they are not alone in this career, and can always approach a senior staff or colleague for assistance.
Armed with new knowledge from the course, participants commented that they now felt more confident to manage clinical trials, as well as navigate tricky situations should they encounter similar situations in future.
Participants engaging in group discussions and hands-on activities such as role-playing.
The next run of CRC Level 1 Programme will be in September 2024. Registrations open from 1 June 2024 to 30 June 2024. Click here for updates of the programme!