Standard Operating Procedures
Standard operating procedures help standardise key clinical trial operations. As a Coordinating Principal Investigator, you are responsible (in consultation with your Sponsor and organisation) for implementing standard operating procedures (SOPs) to ensure that trials are conducted and data is generated, documented and reported in compliance with the protocol, Good Clinical Practice principles 2.13 and 4.2.6, and other regulatory requirements.
SOPs help sites meet two essential requirements of GCP:
- to protect the rights, safety, and wellbeing of participants; and
- to ensure the reliability and credibility of trial data.
Further
information about standard operating procedures can be found in the clinicaltrialsNSW
toolkit.
Who can help?
The National Standard Operating Procedures for Clinical Trials – including teletrials.
Patient information and consent forms (PICF) and all patient-facing materials should be developed with your health consumer representatives and be in plain, easy to understand language. CT:IQ has a created a nationally accepted template and user guide to help you co-create a participant-centred PICF and obtain truly informed consent.
There may also be costs associated with developing communication plans to communicate with the participants you recruit to the trial. .
CT:IQ has also develop a toolkit to assist with developing a Developing Communication Plan, which are not essential but considered best practice.
- The minimum that should be communicated to your trial participants is that the trial is finished and the results have been published. Providing a lay summary of the research outcomes the next steps to implementation and thanking them for their time is also appreciated by participants. Your health consumer representatives can be of particular assistance in developing lay summaries and other participant facing materials. This may be some time after the first participant from your site has completed trial activities, so there is a need to keep participant contact details up to date until this occurs.
- Transcelerate has a Study Participant Feedback Questionnaire Toolkit which includes questions you may want to include in your feedback survey.
- If the trial is long or will take years to reach recruitment, it is good practice to provide research progress updates to site participants, beyond what is clinically required. For example, newsletters providing information about recruitment success, retention rate, expected trial completion or staffing changes; or expressions of gratitude {Glossary, new definition} such as a certificate of completion or a birthday card.