NCI Registration and Renewal Form 1572

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NCI Registration and Renewal (Form 1572)
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Session Goals

• Review the mechanism for registration renewal
• Review how to fill out forms properly
• Describe the common mistakes and pitfalls to
  avoid

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NCI Requirements

• NCI investigator numbers are required for all
  attending physicians who will obtain consent from
  subjects for research related therapy or who will
  write orders for research related therapy.

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NCI Requirements

• NCI requires a centralized registration renewal
  process for all DF/HCC investigators once a year
• This effort is coordinated through the Clinical
  Trials Education Office (CTEO) and Quality
  Assurance for Clinical Trials Office (QACT)
  during the months of May-July
• RENEWAL DURING THIS TIME IS MANDATORY REGARDLESS
  OF WHEN THE PI LAST REGISTERED

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NCI Registration Form Requirements

• Statement of Investigator Form (FDA Form 1572)
• Supplemental Investigator Form (IDF)
• Financial Disclosure Form
• Current curriculum vitae (CV)

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Statement of Investigator-FDA Form 1572

• This form acts as a contract between the
  investigator and the FDA which documents the
  investigators agreement to follow the protocol
  and study obligations and alleges their knowledge
  and skill in conducting the trial

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Statement of Investigator-FDA Form 1572
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Tips for Form 1572

• Every section must be filled out completely
• Do not use SAME AS ABOVE in any section
• Sections 6 and 7 are completed for you
• Section 8 is not applicable for this annual
  renewal
• ORIGINAL SIGNATURE REQUIRED-please use a pen that
  does not make the signature look like a copied
  signature
• Enter in the date the form was signed

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Supplemental Investigator Form
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Tips for Supplemental Investigator Form

• This form normally comes pre-populated from NCI
• Review information to ensure that it is accurate
• Enter in date of Human Subject Protection
  Training (contact CTEO if unsure of training
  date)
• Changes are made in the shaded right hand columns
• SIGN AND DATE

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Financial Disclosure Form
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Tips for Financial Disclosure Form

• MUST CHECK YES OR NO FOR EVERY QUESTION
• If yes, you must list the names of the
  pharmaceutical companies
• ORIGINAL SIGNATURE, DATE AND PRINT NAME OF
  INVESTIGATOR

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Curriculum Vitae (CV)

• Must be a current CV
• CV MUST BE SIGNED AND DATED BY THE INVESTIGATOR

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Completed Forms

• ALL COMPLETED FORMS MUST BE SENT TO THE CTEO AT
  THE FOLLOWING ADDRESS 20 Overland Street, 2nd
  Floor Boston, MA 02115
• Each packet will contain a return address label
  with the CTEO address to be placed over the
  original label
• DO NOT SEND FORMS DIRECTLY TO NCI

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DROP BOXES

• Convenient drop boxes will be located at each
  institution where completed forms can be placed
• DFCI
• Security Booth in Dana Building
• Longwood Galleria-1B (Nancy Kinchlas office)
• Biostatistics-Mayer 2
• BWH
• CWN2 Rm. 225 (Breast Center)
• MGH
• Cox 640 (Dr. Chabners Office)
• BIDMC
• Kirstein Bldg. 170A

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Time Line 2006

• Packets are sent to investigators the first week
  in June
• Packets contain Form 1572, Supplemental
  Investigator Form, Conflict of Interest Form,
  instructions on how to complete the form and a
  return label
• Be on the look out for the red envelope

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Time Line 2006 cont.

• Forms are due back in the CTEO office by June
  26th, 2006
• This allows adequate time for processing and
  sending to the NCI
• When the forms are received by the CTEO, an email
  will be sent to the investigator stating that the
  forms were received and processed

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Incomplete Forms

• Forms that are incomplete or missing information
  will be sent back to the investigator for
  completion.
• This slows down the process and may result in
  suspension from participation in NCI trials

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True or false?

• It is okay to write same as above on the
  Statement of Investigator Form (1572).
• False!!
• All fields must be filled out completely with
  name and address.

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True or False?

• The forms need to have original signatures
  only, no copied signatures will be allowed.
• True!!
• Signatures can not be copied or look like they
  are copied.

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True or False?

• All forms should be sent directly to the National
  Cancer Institute.
• FALSE!!
• Forms should be sent to the CTEO at 20
  Overland St. 2nd Floor or placed in a drop box
  for transportation to the CTEO.

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True or False?

• All the investigator needs to send in to renew
  their NCI investigator status is the FDA Form
  1572.
• FALSE!!
• The CTEO needs to receive all 3 forms and a
  current CV to send to NCI for renewal.

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Contacts

• Clinical Trials Education Office (CTEO)
• 20 Overland St. OS203B
• Boston, MA 02115
• --or
• 44 Binney St OS203B
• Boston, MA 02115
• 617-582-8480 or 617-582-8310
• CTEO_at_dfci.harvard.edu or snelson0_at_partners.org
• WEB SITE http//www.dfhcc.harvard.edu/clinical-re
  search-support/clinical-trials-education-office-ct
  eo/

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• QUESTIONS?