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Clinical Trials Cooperative Group Program Guidelines, August 1996

ATTACHMENT 2 - Sample Format

MEMBER INSTITUTION SUMMARY OF ACTIVITIES

(see text, sections VII.2.A.e. and VII.4.A.)


INSTITUTION:_______________________________________________________

PRINCIPAL INVESTIGATOR:____________________________________________

COOPERATIVE AGREEMENT #______________ DATE____________________

  1. Case accession by calendar year of the current project period (please prepare separate tables for therapeutic and non-therapeutic studies)
From the Member Institution Year 1 Year 2 Year 3 Etc.
         
Phase II        
Phase III        
Pilot        
Subtotal        
% Eligible        
% Evaluable        
From Affiliated Institutions (Funded and Unfunded) Year 1 Year 2 Year 3 Etc.
         
Phase II        
Phase III        
Pilot        
Subtotal        
% Eligible        
% Evaluable        
TOTAL        


  1. Number of follow-up cases at end of calendar year:
From Primary and Affiliated Institutions Year 1 Year 2 Year 3 Etc.
         


  1. Group administrative and scientific participation during the current project period.
  1. Investigator Name
  1. Committee
  1. Activity
     
  1.  
  1. Protocol Chairmanships
  1. Open Protocol and #
  1. Investigator Name
   
  1. Protocols in Follow-up and #
  1. Investigator Name
   
  1. Institutional pilot studies and other research contributions to the Group.
  2. Services to the Group (core lab, site visit, etc) during the current project period.
  3. Number of quality assurance audits of the institution during the current project period, and problems identified, if any.
  4. Disciplinary actions imposed by the Group during the current project period.
  5. Group-related publications (annual bibliography limited to the current project period) authored by institutional investigator(s).
  6. Ranking of institution's performance overall by Group leadership (by quartile; see VII 2 A.b.)

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