RDF19 Poster Detail
|Rationalising Trial Visit Worksheets-making research visits easier, for everyone|
As a new Clinical Research Unit, we soon identified that performing and documenting study visits were cumbersome processes. Study procedures were easily missed e.g. the exact time of venepuncture, which led to data queries and potential protocol deviations. This risked the integrity of the study and our Unit’s reputation. It was sometimes difficult for other staff members to step in and complete a study visit in the absence of a specific nurse. One particularly complicated commercial study prompted our nurses to devise their own check list leading to the development of our current Trial Visit Worksheets.
We now have over 6 years’ experience of designing and refining these documents. They have been positively commented on during both national and multinational site visits and most recently during an MHRA inspection. We would like to share our success with you.
The Trial Visit Worksheets are prepared using a standard template prior to the first patients’ visit. Used as source data, they are based on the protocol study schedule and case report forms, ensuring that all trial-related assessments and procedures are carried out in the correct order for each visit. They start with consent (including version and date) and end with preparation for the next study visit. They are version controlled and may be adapted over the life of the study.
Our Trial Visit Worksheets are used across the whole of R&D in our Trust, ensuring that our patients benefit from streamlined visits, that research staff time is spent efficiently, that protocol adherence is optimised and finally that monitoring is likely to be straightforward.
They help us be patient and inspection-ready.
|Brighton and Sussex Univeristy Hospitals NHS Trust|