Multisite Coordination
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Multisite Coordination

To obtain the benefits of a clinical trial network the processess and communication must be in place to ensure a “one stop shop philosophy”. CTA has its own management team responsible for:

 

  • Compiling regulatory documents to obtain institutional ethics approvals at each participating sites.
  • Assemble budgets, legal agreements and indemnities on behalf of the members so that a sponsor need only deal with core entity.
  • Coordinate invoicing and disbursement of fees from sponsor to member institutes.
  • Monitor patient accruals versus sponsor targets.
  • Process amendments during or prior to a clinical trial.
  • Coordinate collection of serious adverse event reports (SAE)
Mutual Acceptance Program

“Time to approval” and trial initiation can be a long process for a multisite trial. CTA has a mutual recognition process in place with six of its clinical sites and close management/coordination with the other 5. As a result an approval to undertake a study at one member site is recognised within 10 days at other accepting sites.

E-Trackers

CTA supplies sponsors with advice on progress of their regulatory documents to obtain approval and post approval, patient accrual reports.These are issued every 2 weeks.

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