Dear CONCEPTT Collaborators,
As the CONCEPTT Recruitment Phase has successfully been completed, we ask all CONCEPTT collaborators to now focus on data quality. For this purpose, the CONCEPTT Coordinating Centre is planning to perform site monitoring visits to selected sites in the UK, Italy and Canada in the next few months starting in May. In preparation for our upcoming data reviewing and cleaning we would like to recommend the CONCEPTT sites some helpful hints:
- Regularly review and reply to queries in OpenClinica®
- When documenting Adverse Events:
- Prior to entering an AE in OpenClinica®; review the exception list to ensure that the medical event is not listed as an exception.
- Enter a diagnosis or medical condition rather than a symptom. For example: Viral Gastroenteritis rather than Diarrhea, Nausea and Vomiting.
- Please note that the Site Investigator is responsible for determining the AE seriousness, severity, expectedness and relatedness.
- Contact the Coordinating Centre if you need assistance prior to entering an AE in OpenClinica®.
- Follow identified AEs through to resolution. A resolution date is required to properly complete an AE form in OpenClinica®.
- For “ongoing” AEs, the date of resolution is considered when the event is clinically resolved or assessed and, determined to be chronic or stable by the treating physician.
- Please remember to also update the AE outcome (resolved with/without sequelae or unknown) when providing the date of resolution.
- When dealing with challenging study participants who have difficulties complying with scheduled appointments, or refuse certain procedures of the study or have discontinued the use of the device, please remember that:
- CONCEPTT primary outcome for the pregnant cohort is the glycemic control as measured by HbA1c at 34 weeks or at Delivery if prior to 34 weeks therefore, all efforts should be made to obtain that blood sample
Thank you all for your great contribution during the recruitment phase as we surpassed our goal and finished two months earlier!