Study Protocol Configuration

Study Protocol Configuration

User can specify the following study protocol information, which is prerequisite for some of Risk Indicators and predictions. In Study Protocol page, there are sections Study Outcomes and Enrollment Plan with buttons for uploading and downloading Study Outcomes and Enrollment Plan configuration files. See below the details regarding available configuration settings (configuration files).

Study Outcomes

This is the list of data points which are correspondent to study outcomes, mentioned in the study protocol. For referencing a data points there, specify the identifier of eCRF and also identifier of the variable correspondent to that data point in eCRF, or just the identifier of eCRF if all variables there are correspondent to study outcomes. To understand how to source that information, find the list of outcomes in the study protocol and find the identifiers from the annotated eCRF or eCRF metadata.

To specify the outcomes list, use the Study Outcomes section.

  • Click Download. The empty template Outcomes.xlsx file is downloaded if no outcomes list has been uploaded. (Otherwise the Excel file with latest uploaded Outcomes Configuration file is downloaded.)
  • Click Upload. The dialog for browsing Microsoft Excel Worksheet file is opened. You can select Outcomes configuration file there for uploading.

Outcomes Excel configuration file structure and requirements:

  1. It has 1 tab with 3 columns with headers:
    • Form ID column is mandatory. If there is no value in the Form ID column, the row will be skipped. It is needed to specify eCRF ID in 1st column as they appear in EDC data import, for example: STAT or PE.
    • Field ID (optional) If there is value there, it means that this field is selected. If there is empty cell there, it means the whole form is selected (all fields of that form).
    • Visit IDs (optional, comma-delimited) Contains comma-delimited list of visits. There may be white-space around the comma. If there is value there, it means that field value is the study outcome just for these visits. If there is no value here, it means that this field value is outcomes for any visit.
  2. There may be more than one row with the same value of Form ID but different values of Field ID and VisitID. It means that several fields are selected from that form.

This information can be used as input by KRIs, in particular, by standard KRI High Percent of Missing Outcomes (from ‘Golden Standard of KRIs’). The list of outcomes can be changed during the course of study, for example, as a result of a protocol amendment. It is possible to upload the changed configuration as many times as needed. After an updated list is uploaded, that is reflected in the calculated KRI value after the next data processing.

Enrollment Plan

This is the enrollment plan for the study, and also for separate subdivisions of the study organizational structure, for example, countries, sites. It can be changed during the course of study.

Enrollment Plan Section:

  1. Click Download. The empty template EnrollmentPlan.xlsx file is downloaded if no enrollment plan has been uploaded,. (Otherwise, the Excel file with latest uploaded enrollment plan is downloaded.)
  2. Click Upload. The dialog for browsing Microsoft Excel Worksheet file is opened. You can select the Enrollment Plan configuration file there for uploading.

Enrollment Plan Excel configuration file structure and requirements:

  1. Format. Data in the format given in the first sheet of the document is transferred through the data connection as CSV file (the preferred column delimiter - comma, the preferred decimal separator - point). The second sheet with comments is not included.
  2. Headers. There must be 3 columns with headers:
  • Level - whether the name of a site, an ISO 3166-1 alpha-2 code of a country (for example, "CZ") or string "Study". The presence of records for countries and study (high levels) is optional. If records for countries and the study are absent, then it is calculated as the sum of amounts for all sites included in this high level.
  • Date - dates in the format "M/D/YYYY". For every level there must be the recruitment start and recruitment stop dates in the list and some intermediate dates between the start and the stop. The period between the intermediate dates must not be less than the month (approximately). There are first dates of months in the example, but it is not necessary. It can be any day of a month. Also dates there can be more frequent than monthly. If the recruitment goal is set weekly, then dates are first days of every week. It is expected that dates for any level are given as a continuous block from the first to the last date.
  • Enrollment - for every level, 1) for the recruitment start date the enrollment is always zero, 2) for any other date it is the number of subjects enrolled in the period between that date and the previous date which is given for that level. If we take all values for a certain level and sum them up, the result will be equal to the number of subjects enrolled during the whole enrollment period.

3. Warning about synthetic enrollment targets. Consider that the sample data contains monthly enrollment goals, but it does not imply that monthly goals are set for the study by the study administration in reality. For example.: If the goal is N patients for a certain site during the whole enrollment period, and the period duration is K months, then we will assign to each month the enrollment target N/K. In this case, the figures are synthetic, but they reflect the belief that the enrollment pace will be the same during the whole period. And if the study administration assumes something different, for example, that the site will enroll more patients at the end of the period, that difference should be estimated and reflected there.

This information can be used as input by:

  • KRIs, in particular, by standard KRIs High Number of Enrolled Patients and Low Number of Enrolled Patients (from ‘Golden Standard of KRIs’).
  • Metric predictions (on Dashboard) use dates of start and end of prediction taken from the plan as start and end dates of prediction
  • One of metric predictions, the enrollment prediction also uses final target number of enrolled patients for the study also from the plan.

The plan can be changed during the course of study, for example, as a result of a protocol amendment. It is possible to upload the changed configuration as many times as needed. After an updated plan is uploaded, that is reflected in the calculated KRIs values after the next data processing.

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