At clinical research sites, Standard Operating Procedures (SOPs) help define the study team standard practices and daily processes to assure execution of study tasks are in accordance with the requirements. SOPs should contain enough detail to guide the study team through a particular procedure and thereby establish uniformity in the everyday functions of each site.
The quality of clinical trial depends on the integrity of the data and protection of subjects. Study Coordinators (SCs) play an important role in a Site Management Organization to ensure compliance and delivery of clinical trials.
At Clinical Research Malaysia (CRM), a Quality Improvement Project (QIP) has been initiated in January 2016. The QIP aims to improve the site management organization processes in CRM and to direct the organization to achieve its performance. The QIP is mainly divided into three stages i) QIP planning; ii) Project Implementation; iii) Process improvement. In QIP planning, the Project Management Planning is used to ensure the success of the QIP. In stage 2, process improvement was carried out where the Plan-Do-Check-Act model is used for drafting and reviewing the Standard Operating Procedure (SOP). A quality manager is assigned to monitor the progress of the QIP.
A bimonthly meeting was carried out to ensure the project progress is reviewed and supported by the top management team. A quality team was also assigned to assist in the QIP. In 2016, a total number of 110 SCs were deployed at 32 sites throughout Malaysia. These sites include public hospitals, health clinics, National Cancer institute and universities. The challenge of this project is to have one standard SOP for all sites and to meet the project deadline.
The QIP begins with identifying the needs of developing new processes and reviewing of the current processes at sites. Internal and external reviewers then reviewed the SOPs.
For implementation of SOP, two session of SOP trainings were conducted. All SCs must passed the validation assessment (80%) in order to be rewarded with a certificate.
The Clinical Operations team continues to strive for continuous improvement by performing the SOP compliance check followed by internal audit as part of the quality assurance procedures.