Investigation into ‘visualization’ of CRC operational workload and protocol complexity

[Speaker] Kyoko Yasuda:1
[Co-author] Yuki Mihara:1, Kayoko Shono:2, Kazunobu Yoshimura:2, Akihisa Mitake:2
1:Project Management Department Medical concierge service, Site Support Institute Co., Ltd, Japan, 2:Site Support Institute Co., Ltd, Japan

Background: It has been 20 years since the 'Ordinance on the Standards for the Implementation of Clinical Trials' (GCP Ordinance) was enacted to streamline clinical trials in Japan. However, due to ever increasing complexity of clinical trial design and protocol, importance of clinical research coordinator (CRC) has significantly increased. But, this has also led to significant increase in workload for the CRCs. To alleviate this situation, the U.S. has developed a system called 'Tool for Operational Protocol Scoring' (TOPS) that measures CRC operational workload and protocol complexity.

Purpose: To `visualize' CRCs' operational workload and protocol complexity
using TOPS. In addition, compare TOPS results with the Numerical Rating Scale (NRS) used to measure workload of daily operations.
In Japan, CRCs can be separated into two groups, ones that are stationed at medical institutions, and another that are contracted by clinical trial sites via Site Management organization (SMO).
For this research, CRCs contracted by SMO were used.

Method: Approximately 500 CRCs belonging to Site Support Institute (SSI) utilized TOPS that consist of 12 categories to determine the complexity of clinical trials. Rating was 1 for Low, 2 for Moderate, 3 for High complexity. The same CRCs also used NRS to rate ones experience, on scale of 1 to 10. The results were than compared.

Result:With regards to clinical trial complexity, the indications with the highest scores oncology, as well as acute diseases such as cardiology.
With regards to NRS scale, indications requiring extra care and attention, such as oncology, CNS and pediatrics had the highest score.
Although TOPS is an effective indicator of clinical trial complexity, there are functions that CRC undertakes that are not reflected in the categories listed in it. As such, in order to 'visualize' CRC operational workload, further investigation is likely to be required.

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