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  • Office Of Clinical Trials Research Study Application Form

Get Office Of Clinical Trials Research Study Application Form

Ce of Clinical Trials, Room D336 Executive Offices, TCC, Westchester Medical Center along with 1 copy of each of the following: Complete NYMC Application, including the protocol, investigational brochure, consent & HIPAA forms Completed and signed FDA form 1572 (drug studies) or Investigator s Agreement (device studies) Budget (if the study is to be conducted at Westchester Medical Center, including clinics, or requires WMC ancillary services) Clinical Trial Agreemen.

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How to fill out the OFFICE OF CLINICAL TRIALS Research Study Application Form online

Filling out the OFFICE OF CLINICAL TRIALS Research Study Application Form is a crucial step in the process of submitting a research project. This guide provides a clear, step-by-step approach to completing the form accurately and efficiently, ensuring timely review and consideration of your research.

Follow the steps to effectively complete your research study application form.

  1. Click the ‘Get Form’ button to access the application and open it for editing.
  2. Fill in the principal investigator’s information including name, phone number, and email. Ensure all details are accurate as this contact will be essential for follow-up communications.
  3. Provide the primary contact's information if different from the principal investigator, including name, phone number, and email.
  4. Specify the department or division associated with the research study by entering the relevant information.
  5. Enter the title of your research proposal clearly and concisely to reflect the focus of your study.
  6. Indicate all sites where you will conduct the study by checking the appropriate boxes.
  7. Answer whether the study requires participants to be inpatients at any point. Select 'Yes' or 'No'.
  8. Confirm if all study activities are limited to the outpatient setting by selecting 'Yes' or 'No'.
  9. If activities will occur at any WMC clinic, specify the clinic and the related study activities.
  10. Indicate if WMC ancillary services are required for the study and check which specific services apply.
  11. List all tests or procedures that will be funded by the study sponsor that are not billable to third-party payers.
  12. Provide information on any drugs that the sponsor will supply at no cost.
  13. Detail any specific ancillary services needed, procedures involved, and frequencies as applicable.
  14. Answer the coverage analysis question regarding the trial's qualification under the National Coverage Determination.
  15. If applicable, provide details regarding hospitalization needs for study participants.
  16. State any special procedures involved in the study and identify who will perform them.
  17. If the study involves an investigational device, confirm and provide details about the device.
  18. Submit the form along with any required documents including the protocol, budget, agreements, etc.
  19. Once all fields are complete, review the form for accuracy, save your changes, and download or print a copy for your records.

Complete your OFFICE OF CLINICAL TRIALS Research Study Application Form online today for a thorough and timely review.

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How to Join a Clinical Trial Look for options. Review eligibility criteria. Contact the study organizers. Review the study description. Learn about informed consent.

"PHS" means the Public Health Service, an operating division of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated.

Key to determining if research involves human beings as subjects are these definitions: What is a “living individual?” The specimen/data/information must be collected from live subjects. Cadavers, autopsy specimens, or specimens/information from subjects now deceased in not human subjects.

Is proprietary/privileged information included in the application? This field is required. Patentable ideas; trade secrets; or privileged, confidential commercial, or financial information should be included in applications only when such information is necessary to convey an understanding of the proposed project.

Informed Consent Form is a mandatory document to enroll in a clinical research study. This document provides detailed information to the participant about the study, including its purpose, procedures, potential risks and benefits, confidentiality, and the participant's rights.

Use the optional PHS Assignment Request Form to list expertise needed to review your application, exclude reviewers, and request an institute assignment.

Completion and submittal of a Personal History Statement (PHS) is the first step of the Background Investigation. The PHS requires compilation of extensive biographical information, fingerprinting, and an interview with a background investigator.

The essential documents for clinical trials are the following: Investigator's Brochure. Clinical Study Protocol. Subject Information and Informed Consent Form. Clinical Study Reports. Case Report Form (CRF)

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
Privacy Notice
Legal Hub
Content Takedown Policy
Bug Bounty Program
About Us
Help Portal
Legal Resources
Blog
Affiliates
Contact Us
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate WorkFlow
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232