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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:

  1. 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:
    1. the electronic data capture systems (EDC) used to collect the data
    2. who entered/collected the data?
    3. 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?
    4. Was the data reviewed/verified by the clinical investigator or a designated study staff?
    5. Were the study personnel adequately trained in data collection procedures?
  2. Question 8: In reviewing the protocol regarding the subject enrollment please address the following questions/comments:
  3. 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.
  4. 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.
  5. General comments about the registry study protocol:
  6. 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.
  7. 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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