Manual Castor SMS (English) - For research team members

• Create a new study

  Add a new study Go to the 'Studies' tab. Click on 'New study'.  Fill in the required fields.  Click on 'Continue' to add the study. The new study will then be added to Castor SMS. Before the study can...

• Submit study for approval

  The ‘Check & Submit’ tab of a study shows an overview of the required documents and fields that need to be completed before the study can be submitted. Please note that submission and approval flows c...

• Manage study documents

  Add documents to a study Go to the 'Studies' tab. Open the study. Go to the 'Documents' tab. Click on 'Upload document'. Fill in the form.  Select one or multiple documents that you want to add to the...

• Manage study documents (TMF)

  Add documents to a study Go to the 'Studies' tab. Open the study. Go to the 'TMF' tab. Click on '+ Documents'. Select one or multiple documents that you want to add to the study. Please note that only...

• Invite users to a study

  Adding new users to the study allows them to access the study and applicable documents. Add user to a study Go to the 'Studies' tab. Open the study. Go to the 'Study team' tab. Click on the 'Add user'...

• Add participating sites / centers to a multicenter study

  It is only possible to add participating centers to a study when ‘Multicenter, initiating center’ is selected in the ‘Multicenter study’ dropdown menu found in the study’s ‘Main’ tab. Add a new center...

• Manage study amendments

  Add study amendment Go to the 'Studies' overview. Open the study. Navigate to the 'Amendments' tab. Click on 'Add amendment'. Fill in the form.  Click on 'Save'. The amendment is now added to the stud...

• Overview of the approval requests

  Before a study can be locally approved, all added approval requests must be accepted. You can find an overview of the study approval requests in the study’s ‘Approval requests’ tab. The overview inclu...

• Manage study monitoring

  Monitors and monitor visits can be managed at study level. Add a monitor Go to the 'Studies' tab. Open the study. Navigate to the 'Monitors' tab. Click on 'Add new monitor'. Fill in the form.  Click o...

• Manage study progress

  Once the study is locally approved, data on study progress can be collected. There are two methods to manage study progress: Progress reports Inclusion numbers Add progress report Go to the 'Studies' ...