Table 3 Structure and content of dashboard tabs

Participant Safety and Rights

Informed consent

Informed consent

In case of a re-consent this tab can provide an overview of patients patients who have previously not been able to give consent themselves

To ensure patient rights and support of re-consent process through site-specific reminders, list of patients that still need a re-consent.

Optional

AE/SAE reporting and documentation

AE/SAE

Provides an overview of timeliness and completeness of AE/SAE entries

To ensure that all AE/SAE forms are complete and that the date of first entry is within the required reporting timeframe

Generic

Inclusion/exclusion

Safety

In case of safety-relevant inclusion or exclusion criteria, a verification of relevant information available in the database can provide additional security (e.g. blood pressure has to be within a certain range – check for the entry of blood pressure in the database)

To provide the option for additional checks for inclusion/ exclusion criteria besides the marked list of criteria in the eCRF

Optional

Overall Study Management

Recruitment

Recruitment

Recruitment trajectories for expected and actual recruitment in total and per centre (Supplementary Fig. 2)

To monitor the progress of participant recruitment enabling early action in case of slow recruitment.

Generic

Patient Characteristics

Relevant patient characteristics are summarized and presented (e.g. gender, age, background of treatment)

To inform the study team on the accuracy of inclusion/exclusion criteria and provide an overview of the sample population in terms of relevant characteristics

Generic

Retention

Retention

Patients who have ended the study resulting in missing outcome data, reasons for leaving the study, kind of data collected before study end (Primary outcome data available) (Supplementary Fig. 3)

To monitor the progress of participant retention, consider reasons for ending study in recruitment. Time point of ending the study important for amount of data analysable.

Generic

Study procedures and endpoint assessment

Bio sampling (e.g. blood samples)

Overview of samples taken and availability of sample results

To support sample management in terms of localization and status of bio sample. Important for biomarker determination.

Optional

Imaging quality

Automated and visual verification of imaging data quality, e.g., for MRI or CT

To enable early adjustments in case of low quality imaging data and ensure that the imaging data is analysable.

Optional

Participant schedule:

Follow-up visits

Overview of follow-up visits with a particular focus on visits where primary outcome data is collected. (Fig. 2, Panel A)

To assist in integrating follow-up visits on time into the daily clinical routine might be difficult for trial sites. Support through reminders for due visits can be initiated through the dashboard.

Optional

AE/SAE management

Safety management (SAEs, AEs)

The Safety tab provides an overview of SAEs and AEs that have been reported in the study and information on severity and outcome of SAEs/AEs (Fig. 2, Panel B)

To estimate potential safety issues (e.g. SAEs occurring more often in one study arm, number of SAEs in total, number of patients with SAE)

Generic

Device/ Medication Management

Administration

Accountability/ storage

Medication

Overview of medication consumption based on number of patients and their current position in the medication plan per protocol and comparison with IMP stock at sites

To assist in the managing of IMP stock overview and enable reminders for restocking

Optional

Study Data

Data quality – completeness, consistency, timeliness

Documentation/ storage

Data Quality

Completeness of forms (Primary end point, secondary endpoint, SAE/AE forms)

Timeliness of data entry,

Number of queries, status of queries (open, resolved)

(Supplementary Figs. 4,5)

To increase awareness of items missing in the database

Trial sites may have different challenges when integrating a trial in their daily clinical routine and therefore need support in different aspects of the study conduct. Completeness and timeliness of data entry as well as query management constitute indicators for need of support.

Query status helps the study monitor to decide which centre needs more assistance/ on-site visit.

Generic