
 

Registry Protocol Response to Questions - Provenge, April 14, 2010


 
(System Info - 125952 TULL LORI 04/14/2010 08:58:37 TULL)


From: Tull, Lori
 Sent: Wednesday, April 14, 2010 8:53 AM
 To: 'Kim, Helen'
 Cc: Kannan, Bhanu; Finn, Thomas; Bross, Peter F (CBER); George, Bindu
 Subject: Registry protocol response to questions

Hi Helen,

The following comments from the bioresearch monitoring group (BIMO) are in 
response to your questions on your plan for the registry study:

Question 6: You need to assure us that any data collected for baseline 
prognostic factors and the eligibility to participate in the registry study 
determination should include the source documentation. The following data 
collection questions should be addressed in order for BIMO or any other 
regulatory authority and for your QA/QC auditors to be able to conduct any 
future inspections of the registry study:
  The draft protocol section 6.7 describes that subsequent follow-up of the 
  subjects will be via telephone contact, facsimile, or EDC that will occur 
  every 3-6 months for a minimum of 3 years for every subject participating in 
  the study. The data collected during the follow-up should describe: the 
    electronic data capture systems (EDC) used to collect the data
    who entered/collected the data?
    was the data directly entered on the CRF and by whom? if the data was 
    directly entered on the CRF will it be the source document for that data 
    variable?
    Was the data reviewed/verified by the clinical investigator or a designated 
    study staff?
    Were the study personnel adequately trained in data collection procedures?

  Question 8: In reviewing the protocol regarding the subject enrollment please 
  address the following questions/comments:
  The draft protocol section 4.0 states that ?each patient will be screened to 
  determine if he meets the eligibility criteria.? Please describe the screening 
  and enrollment procedures in detail including such information as the 
  demography, medical history, screen failures, the reason for screen failure 
  with dates of such determination and the need to document screening and screen 
  failure information at the registry sites enrolling subjects for the study.
  The draft protocol section 4.1 states that at the registry site the 
  investigator will follow the approved product label for determining the 
  eligibility of the prospective subjects to participate in the registry study. 
  If the investigators are required the follow the product label we request that 
  you adequately train the study personnel on the contents of the product label 
  regarding eligibility determination and require the sites to prospectively 
  note any deviations that may have occurred.
  General comments about the registry study protocol:
  Please identify any data that will be directly entered on the CRF and thus 
  will be the source document in turn for that data variable.
  Please ensure that the clinical investigators are aware that they are 
  participating in a clinical study in subject enrollment, informing the 
  prospective subject about the study procedures and obtaining the informed 
  consent, leukapheresis, product administration, subject follow-up, and the IRB 
  oversight of the study.

Best Regards,

Lori

Lori A. Tull, RAC
 Regulatory Project Manager
 Office of Cellular, Tissue, and Gene Therapies
 Center for Biologics Evaluation and Research
 (301) 827-5359

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