Launching and completing the study

Transcript:

  •  To be able to collect the data, the study needs to be live
  • "Going live" means that your study is 'in progress' and you can start collecting data. 
  • When the study is not live only users with at least one management right can access it
  • Once live, invited users will be able to access the study and perform actions depending on their rights
  • Setting the study to live have consequences which you need to consider:
  • When the study is first set to live, you will be shown the price for your study and receive an invoice.
  • The price of the study is based on the information you enter in the 'study details' form. 
  • It is important to fill out this form as completely as possible. 
  • You will also receive the full pricing overview by email after you set your study to live for the first time. 
  • In case you have received a billing code e.g. if you are from an institute with an institute license for Castor, you will need to enter this in the billing code details section of the 'Settings' tab.
  • When the study is live, it is not possible to make changes to your study forms. 
  • If you need to make further changes to your eCRF, the study must be changed to 'not live'. 
  • Making changes after going live might affect existing data, as the changes are reflected in all the records
  • We recommend thoroughly testing your eCRF thoroughly before going live to ensure that everything works as expected.
  • Be aware that after going live, removing study data will no longer be possible in accordance with Good Clinical Practice (GCP).
  • For example, records can not be deleted and will need to be archived instead. 
  • Archived records will not get exported nor influence your study in any way, but will still be traceable/recoverable in case of an audit. 
  • The same applies for survey invitations.
  • Changing the study to 'not live' means that any users without management rights will not be able to access the study for the duration of time that the study is not live. 
  • Taking your study off live will not affect your study or your collected data in any way.
  • When a study has ended, there are several steps you can take to complete the study. We recommend to lock your records, export a copy of your data, ensure that the study is set to not live and that all unnecessary user rights are removed. 
  • You can check the course on ‘Data entry’ to learn how to export a copy of your data from Castor.
  • For the user rights, we suggest that the study admin is left as the only user. You can remove all user rights except view, export and Manage records rights, to be able to access the study when not live.
  • If you prefer not to see the study in your study list, then you can remove yourself as user completely.
  • The study data will be stored in Castor for 15 years at no additional costs. This is done for GCP traceability purposes, and data is stored even if there are no users in the study.