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Regular approach

Steps

  1. LPOs create the COVID eCRFs.
  2. Push the COVID eCRFs into each of the Rave study by ‘Rave study amendment’ process

 

Advantages of the regular approach:

  • Straight forward and no change in work flow for the site users.
  • Does not need any new study invites for the site users

Cons:

  • LPOs need to go through complicated study amendment process that involves the study data migration.
  • Takes long time to complete the study amendment for all the required Rave studies

 

Master study approach. See the possible Rave study set up at the end.

Steps:

  1. Set up the master study in Rave  (LPO) with just the  COVID eCRFs. Let CTSU know when the set up is done.
  2. CTSU will run a batch job to invite all the site users with Rave role  from all the sites that have enrolled at least one patient in any of the <LPO> study in that URL. This will be a one time push that will take about five days for CTSU to complete. It will not take care of any new persons with Rave role added to the roster at a later date. If needed, CTSU can do a delta push once every two weeks.
  3. LPOs (who initialize patients in Rave on their own) should initialize the patients in the master study with the patient ID format ‘Protocol_number-PatientID’.
  4. For those groups that CTSU initializes the patients in Rave,  CTSU can initialize patients in the master study also. For this, the master study should be set up with the standard subject enrollment form. This will result in  lot of patients (about 30,000 patients for each NCTN) in the master study. (Note: If you want to minimize the number of patients in the master study, a simple application (or another Rave study?) outside of the Rave can be set up to trigger the patient initialization. But that will extend the overall timelines). This will take about 5 days for CTSU to complete.
  5. After the above steps, sites can start entering the data in the master study.

 

Advantages of the Master study approach:

  • LPOs do not need to go through complicated study amendment process that involves the study data migration
  • May have long term value with similar collection of uniform data across many studies

Cons:

  • Site users need to be trained to enter data into the master study. Change in work flow for the site users.
  • New study invites for the site users need to be sent.
  • The master study uses patient ID format that is different from the original study patient id
  • If LPOs were to amend the master study in future, it will be more complicated due to the vast number of patients.


In conclusion, the master study approach answers the study amendment/migration issue but It has its own disadvantages.



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