Sites

Trial sites (centres) must be added to the system before adding or randomising a participant, updating a code list, or creating investigator accounts. Sites must also be set to Recruiting before participants can be added.

Administrators can add sites by clicking on the Sites link in the top menu, followed by the Create a new site link.

Site identifier

The site identifier can be any alphanumeric text and may be used in some trials to create a participant identifier of the form SNNN (where S is the site identifier and NNN is a sequential number, either within or across sites).

Note it is not possible to change the site identifier if a site has associated records, such as user accounts, participants, kits in the code list or allocations in a randomisation list stratified by site.

Timezone

The timezone of a site affects the display of randomisation dates and times generated by the system, such as date/time of randomisation, unblinding and marked in error. It is also used by validation rules such as checking whether a date is in the past. Other date/times, such as timestamps on forms, are usually displayed in GMT timezone (UTC).

Creating a new site

Note that sites cannot be deleted if they have associated records, such as user accounts, participants, kits in the code list or allocations in a randomisation list stratified by site.

Target recruitment

The target recruitment can be specified for sites by entering the target number of participants to be recruited at each site and the target date (by which the target recruitment is expected to be reached).

When the target recruitment is set, a fill bar will appear next to the site name on the sites list, indicating the progression of recruitment at the site. On the site page, a box will also appear showing the target recruitment.

An estimate of the average (mean) number recruited per month will be shown once two or more participants have been added to a site. A message is shown indicating whether the target is likely to be met by the target date given the average recruitment rate. For blinded trials, the average recruitment estimate can be useful for predicting how fast stock gets used at the site, and so help pick the target and restock levels for automatic site restocking.

Once the target is met, a message is displayed, but recruitment can still continue at the site past the target. To prevent recruitment at a site, you must change the Recruiting setting to No (on the site page).

Viewing sites

Automatic restocking and shipments

For trials with a code list, you may see automatic restocking and shipments sections. See site restocking for help on these features.