Review of Cv of Principal Investigator by ycz20868


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									   Post-Approval Monitoring Program
   IND/IDE Responsibility Checklist

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Principal Investigator:                                   Date of Study Review:

Department/Division                                       IND/IDE holder

Protocol Title:                                           IND/IDE #:

Reviewer:                                                 IRB #:

FDA Regulations                                           Corresponding Onsite Documents
CFR 312 / 812
Regulatory documentation
1. As the Sponsor, maintain an effective IND/IDE          All correspondence with FDA including:
 Protocol Amendments
           New Protocol                                  o Original IND/IDE application (including 1571)
           Changes to existing protocol                  o FDA letter of no objection
           New Investigator
 Information Amendments                                  o Amendments (w/ 1571)
           New technical information                     o IND/IDE Safety reports (w/ 1571)
           Discontinuation of clinical investigation               o Evidence of correspondence to other
 IND/IDE safety reports                                              investigators
           Written reports (e.g. MedWatch 3500A)                   o N/A
            to FDA and all participating investigators    o Annual Reports (w/ 1571)
            within required timeframe                     o Correspondence with FDA
           Follow-up information to a safety report      o Other:
            should be submitted as soon as available
 Annual reports
           Within 60 days of the anniversary date that
            the IND/IDE went into effect

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                                                                                                    Form Date 7/13/06
   Post-Approval Monitoring Program
   IND/IDE Responsibility Checklist

2. As the Investigator, assure IRB review and             IRB documentation
                                                          o Initial review
                                                          o Continuing review
                                                          o Amendments
                                                          o Adverse event reports
                                                          o Protocol deviations

                                                          o Current IB/Device manual
                                                          o Other IRB correspondence

Qualified Investigators
1. As the Sponsor, selecting qualified                    For each site Investigator; o Not applicable
investigators (a and b apply only if multicenter trial)   o Signed FDA form 1572 /Investigator
a. Selection PIs qualified by training and experience     Agreement (IA)
b. Investigational product will be shipped to only        o CV(s) (all names listed on 1572 or IA)
those investigators participating in the study            o Financial disclosure for PI and those listed on
c. Obtain information from selected PIs                   1572/IA; written memo disclosing any financial
d. Maintain complete and accurate records                 conflicts/interest
 involving Investigators' financial disclosure            o Clinical protocol

2. As Investigator, conduct study according to            Have you Review guidelines applicable to study?
signed investigator statement, protocol, and
applicable regulations;                                   o Violation/deviation
  Report violations/deviations to IRB;                   o Adverse event reporting requirements
  Protect rights, safety and welfare of subjects;              o UC IRB
  Promptly report to IRB any "on-site" adverse                 o FDA
events in accordance with institutional                   o Informed consent
requirements;                                             o Recruitment
  Obtain informed consent in accordance with
provisions in 21 CFR 50

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                                                                                                       Form Date 7/13/06
   Post-Approval Monitoring Program
   IND/IDE Responsibility Checklist

1. As the Sponsor, ensure ongoing monitoring         o Documentation of safety monitoring plan
investigations                                       o Documentation of data monitoring plan
a. Select monitors by training and experience
b. Ensure proper monitoring                          Monitor of study:
c. Ensure PI compliance or discontinue shipments     o PI
of the investigational drug/device                   o Other:
d. Review and evaluate drug/device safety and
effectiveness                                        o All Correspondence with monitor; o N/A
e. Discontinue investigation within 5 working days   o Monitoring log
when unreasonable and significant risk to subject
are identified                                       Who will be reviewing safety data:
                                                     o PI       o DSMB
                                                     o Medical Monitor      o Other

Record Keeping
1. As the Investigator, maintain adequate and        o Source data
accurate case histories on each subject's            o Progress notes
participation in the trial                           o Concomitant medications recorded
                                                     o Subject eligibility documented

                                                     o CRFs

                                                     o Appropriately documented consent forms
                                                     o Documentation that informed consent was
                                                     obtained prior to study procedures
                                                     o Documentation that subject was given a copy
                                                     of signed and dated consent form

                                                     o Signature/date of staff obtaining data

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1. As the Investigator, ensure control of            o Enrollment log/Randomization log

                                                                                                 Form Date 7/13/06
   Post-Approval Monitoring Program
   IND/IDE Responsibility Checklist

investigational drug/device                          o Delegation of Responsibility log
  Drug/device will be administered only to those
subjects enrolled in the clinical study and under
investigator or designee's supervision

2. As the Investigator, record of drug/device        Drug/device Receipt
disposition                                          o Drug/device received from Industry
a. Maintain adequate record of receipt and                     Drug/device accountability log includes:
shipment of investigational drug/device                     o Receipt date
b. Assure return of all unused investigational              o Quantity
drug/device from individual investigators                   o Lot #
participating in trial or authorize alternative             o Return/disposition
disposition of unused product                               o Method of disposal
c. Maintain written records of any disposition of
the drug/device                                      o Drug/device manufactured onsite

                                                     Drug/device Shipment
                                                     o Single center study - no drug/device shipment
                                                     o Drug/device shipped to multiple sites
                                                       Drug/device accountability log includes:
                                                            o Date
                                                            o Destination
                                                            o Who shipped
                                                            o Quantity
                                                            o Lot #
                                                            o Return/disposition
                                                            o Method of disposal

                                                     Drug/device dispensing record including:
                                                     o Research Pharmacy will mange drug
                                                     o Date
                                                     o Lot #/device #
                                                     o Quantity
                                                     o ID of subject administered/implanted
                                                     o Disposition/record of return
                                                     o ID of person dispensing

                                                     o Return of drug/device, count & reason
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3. As the Sponsor, will inform other investigators   o Current Investigator's Brochure/Device
about the investigational product (if applicable).   Manual
All sponsors will keep each investigator informed

                                                                                                 Form Date 7/13/06
   Post-Approval Monitoring Program
   IND/IDE Responsibility Checklist

of new observations discovered by or reported to     o Single study center
the sponsor on the investigational product.          o Multi-center study
                                                                o Plan to distribute updated information
                                                               to site Investigators about product, safety
                                                               information, etc

1. As the Sponsor or Investigator; Inspection of     Upon request, permit FDA officer to access, copy
Investigators records and reports                    and verify any records or reports made by the

                                                     o Basic review of FDA inspection procedures

Communication with Sponsor or Investigator, if applicable
1. Transfer of obligations from the IND/IDE          o Written documentation on site describing
holder                                              transfer of responsibility
                                                     o N/A

2. Investigator Reports                               o All pertinent correspondence between sponsor
a. Progress reports                                  and investigator (enrollment numbers, adverse
b. Safety reports                                    events, financial information and any changes in
c. Final reports                                     financial information)
d. Financial disclosure reports                       o N/A

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3. Correspondence with sponsor, monitor, and         o Sponsor (if applicable)
FDA (if applicable)                                  o Monitor (if applicable)
                                                     o FDA (if applicable)

                                                                                                   Form Date 7/13/06
   Post-Approval Monitoring Program
   IND/IDE Responsibility Checklist

Additional GCP documentation
1. Laboratory Documentation                          o Current laboratory certification
                                                     o Laboratory normal values
                                                     o Laboratory Director's CV

2. Documentation of study staff signature/initials   o Staff signature log


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Comments (cont.)

                                                                                          Form Date 7/13/06
Post-Approval Monitoring Program
IND/IDE Responsibility Checklist

                                   Form Date 7/13/06

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