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DANA-FARBER / HARVARD CANCER CENTER STANDARD OPERATING PROCEDURES FOR CLINICAL RESEARCH TITLE Subject Protocol Registration Page 1 of 4 SOP QC-804 Effective Date 11/8/11 1.
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How to fill out subject protocol registration
How to fill out Subject Protocol Registration
01
Gather all necessary information about the subject and the protocol.
02
Access the Subject Protocol Registration form through the designated platform.
03
Fill in the subject's identification details, including name, age, and contact information.
04
Provide a detailed description of the subject protocol, including objectives and methodologies.
05
Include any relevant historical data or previous registrations for the subject.
06
Review your entries for accuracy and completeness.
07
Submit the form electronically or print it for manual submission if required.
Who needs Subject Protocol Registration?
01
Researchers conducting studies involving human subjects.
02
Clinical trial coordinators managing subject recruitment.
03
Institutions facilitating research compliance and oversight.
04
Ethics review boards needing to evaluate subject protocols.
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People Also Ask about
What is the unique protocol ID for clinical trials?
The Clinical Trial Protocol ID (0012,0020) is the number or character sequence used by the Clinical Trial Sponsor to uniquely identify the investigational protocol in which the subject has been enrolled.
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What is Subject Protocol Registration?
Subject Protocol Registration is the process of documenting and registering the details of a study protocol with relevant regulatory bodies, ensuring compliance and facilitating transparency in research.
Who is required to file Subject Protocol Registration?
Researchers and sponsors conducting clinical trials are typically required to file Subject Protocol Registration to comply with regulatory standards and ensure ethical conduct.
How to fill out Subject Protocol Registration?
To fill out Subject Protocol Registration, researchers must provide detailed information about the study design, objectives, participant criteria, and methodology, often using a standardized form provided by regulatory agencies.
What is the purpose of Subject Protocol Registration?
The purpose of Subject Protocol Registration is to promote transparency in research, protect participant rights, and enhance credibility by making study information publicly available before the trial begins.
What information must be reported on Subject Protocol Registration?
Information that must be reported includes the study title, purpose, primary and secondary outcomes, eligibility criteria, study design, intervention details, and contact information for the responsible party.
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