Pfizer_nAbCyte Hemophila B

In what region is the test being ordered?
By submitting this form, I agree to receive electronic communications from both Labcorp and Marken?*

Marken is a vendor who will provide shipping instructions, pick up samples, and deliver them to the performing lab.

Account Information

Phone
Phone
Phone
Phone
Phone

Institutional Review Board (IRB)

FDA regulations require the healthcare provider to obtain approval from the convened IRB before use of a Humanitarian Device Exemption (HDE)

Affiliation*

Select one

Some institutions require that an internal review of the HUD program be conducted prior to submission to a central IRB. Does your institution require the HUD program be reviewed prior to going to WCG?

Contact your local IRB to determine what is required prior to submission to WCG IRB. Once you receive approval send a copy of your approval to nAbcyteHemB@labcorp.com and then we will submit your application to WCG IRB on your behalf.

Contact your local IRB to determine how to move forward. Let them know that WCG IRB is the selected central IRB.

If there is an IRB overseeing your site, contact them to understand what is required for you to obtain approval for this program.


Once you receive approval send a copy of your approval to nAbCyteHemB@labcorp.com.


Please note: Any Local IRB Fees incurred will not be reimbursed.


If you have IRB questions contact nAbCyteHemB@labcorp.com.

Treating Physician History*

Has the treating physician or any other personnel who will be involved in this treatment had any of the follow:

  • FDA Warning Letter
  • NIDPOE (Noticed of Initiation of Disqualification Proceedings and Opportunity to Explain)
  • Suspension or termination by an IRB
  • Suspension by a federal or governmental agency (such as FDA, HHS, or Health Canada)
  • OHRP Determination Letter, Health Canada Inspection Letter with observations, or similar
  • Form FDA 483 in the past 5 years

-OR-

Has the treating physician or any other personnel who will be involved in this treatment had any of the following denied, revoked, suspended, reduced, limited, placed on probation, not renewed, relinquished, sanctioned, fined, or subject to disciplinary action?

  • Clinical privileges at any site
  • DEA licensure
  • Fellowship/board certification
  • Medical licensure in any state, nation, or province
  • Membership on any hospital staff
  • Prescribing privileges
  • Professional sanctions including fines and public reprimands
  • Professional society membership
  • Research privileges at any site

-OR-

Is there any action or investigation currently pending before any court of law, federal agency, or state licensing board concerning the professional conduct of the treating physician or any other personnel who will be involved in this treatment in that individual's capacity as a research investigator or as a clinician?

Please email nAbCyteHemB@labcorp.com for additional information.

Emergency Use*

Can you safely wait to treat the patient until an IRB approves the use of the humanitarian use device at your facility? (IRB review takes up to ten business days.)

Has another IRB or IRB chair reviewed this treatment at this site and declined to approve or concur with the use?*
Has another IRB or IRB chair suspended or terminated approval of this treatment?*
Is oversight being transferred to this IRB from another IRB?*

Please attach below the following documentation:

  • Principal Investigator's current medical license
  • Submit copies of all current medical licenses showing the issuing authority, license number, and expiration date

Company/Institution/Organization

Which of the following best describes this site's function?*
Will you comply with HIPAA?
Will procedures be performed in a private setting?

Privacy refers to persons’ interest in controlling the access of others to themselves, such as the ability to control who sees them, hears them, touches them, and has access to their private information. Additional privacy interests include the time and place where individuals provide information, the nature of the information provided by the individuals, the nature of the individual's experiences during the trial, and who receives and can use the information.

Consent Document Preference*
Financial Interest Disclosure*

Does the treating physician, the treating physician's immediate family, or any other personnel involved in this treatment or their immediate families, have any of the following financial interests in the entity that is manufacturing the treatment?

  • Any remuneration from the entity in the previous twelve months that exceeds $5,000, when aggregated for the individual and their immediate family.(Remuneration includes salary and any payment for services not otherwise identified as salary, such as consulting fees, honoraria, or paid authorship)
  • Any equity interest in the entity. (Equity interest includes any stock, stock option, or other ownership interest)
  • Any intellectual property rights and interests (e.g., patents, copyrights)
  • Any governance or executive relationship with the entity (e.g., board of director, CEO)

Please attach all relevant documentation

Drag and drop files here or

By checking this box, I confirm that:

  • I am the treating physician or treating physician’s designee authorized to submit on behalf of the treating physician.
  • The treating physician has full awareness of the information within this form.
  • The treating physician holds a valid medical license in the state in which the procedure will be performed.
  • The information within this form is accurate and complete.
  • The treating physician will:
  • Not commence treatment until receipt of the IRB approval letter.
  • Comply with all requirements and determinations of the IRB.
  • Protect the rights, safety, and welfare of the patients being treated.
  • Personally provide the treatment.
  • Submit proposed modifications to the IRB prior to their implementation. Not make modifications to the treatment without prior IRB review and approval unless necessary to eliminate apparent immediate hazards to the patient.
  • Submit continuing review reports.
  • Notify the IRB when there are no other planned uses at the facility and all devices are returned.
  • Promptly report to the IRB the information items listed in the IRB's "Prompt Reporting Requirements” available on the IRB's Web site.
  • Ensure that consent is obtained and documented.
  • Promptly notify the IRB of any change to information provided on this form.


Financial Interest Disclosure

Full Name

Select role or relationship of individual from this list*

Select all that apply.


You are not required to disclose financial interests in diversified mutual funds or similar instruments in which you have no control over the equities held by the fund.

By checking this box, I confirm that:

  • The information within this form is accurate and complete
  • I am the Principal Investigator (PI) or the PI's designee authorized to submit on behalf of the PI
  • I will report changes to this disclosure to the IRB within 5 business days

LINK

Do you want to be set up with LINK?

Please provide the First Name, Last Name, and email address for each person you want to have a user for LINK

Samples

Are samples picked up at the Site address?
Phone
Phone

Region not currently available

Thank you for your interest! This program is not currently available in your region. If you would like any additional information please contact us at nABCyteHemB@labcorp.com or via the contact link provided on the previous page.

Canadian Spam Policy

Thank you for your interest! In order to enroll in this program you would need to opt in to receiving communications from both Labcorp and Marken.