AOCSC program



The minimum site requirements for obtaining the status of “Qualified AOCSC” are:

  • Two investigators must be adequately trained in the applicable guidelines as provided by AOCID
  • At least one study coordinator (study nurse) must be trained in the applicable guidelines as provided by AOCID
  • Level I & II sites must be willing to implement a quality management system with Standard Operating Procedures (SOPs) as provided by AOCID. Should a site have SOPs already in place, they can submit these for inspection to see if they meet the AOCSC requirements and adapted if necessary to ensure standardization across all AOCSC qualified sites.​

Level II: This level is tailored for sites that conduct prospective, randomized clinical studies. The site must show that it has a dedicated and properly trained team for conducting clinical research studies. The site must have, or be willing to put in place, a quality assurance system as prescribed by the AOCSC program.

The candidate clinics have to be willing to invest about 3 - 10 working days (i.e., 3 - 10 days FTE) to obtain the qualification (depending on the prior availability of standard operating processes and the current status of Good Clinical Practice training of the staff).

More Info: A set of SOPs is implemented at the clinic to define and ensure the quality of the work performed during clinical investigations. The candidate clinics are evaluated and trained in an on-site process. A dedicated team for clinical studies is available, including an assigned position for study coordination (or access to a Clinical Trial Unit is available).

 
Level I: This level is reserved for sites that meet all of the abovementioned standards and have one or more staff members with experience acting as a principal coordinating investigator.
 

More Info: A Level I AOCSC is able to perform and participate in prospective randomized clinical investigations. A set of SOPs is implemented at the clinic to define and ensure the quality of the work performed during clinical investigations. The candidate clinics are evaluated and trained in an on-site process. A dedicated team for clinical studies is available, including an assigned position for study coordination (or access to a Clinical Trial Unit is available). At least one member of the dedicated clinical investigation team at the study center has to have proven experience of acting as a Principal Coordinating Investigator (PCI). As a future option, one of the investigators in the team may be able to perform clinical investigations as a sponsor investigator.

 
 
 
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