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Study Files
It is suggested that each study team maintain ___ types of separate study files:
• ______ Study File/Binder• ______ Study File/Binder
• ______ File/______ for Participants
These study files can be maintained as ______ binders or ______ together in ______ large binder.
It is suggested that each study team maintain 3 types of separate study files:
• Regulatory Study File/Binder• Administrative Study File/Binder
• Clinical File/Chart for Participants
These study files can be maintained as separate binders or compiled together in one large binder.
Study Files - Regulatory
Suggested Documents/Tabs That Should Be Maintained in the Regulatory Binder/File
• Completed Form FDA ______ (Statement of ______)• ______ for the Principal Investigator and Co-investigators
• ______- Approved Documents (Protocol Narrative, Consent Form(s), etc)• ______ Amendments• Copies of Laboratory ______ and ______ Ranges• Investigator ______• Other Related Items That Are Specific For Your Study
• Completed Form FDA 1572 (Statement of Investigator)• Curriculum Vitae (CV) for the Principal Investigator and Co-investigators • IRB- Approved Documents (Protocol Narrative, Consent Form(s), etc)• Protocol Amendments• Copies of Laboratory Certification and Normal Ranges• Investigator Brochure• Other Related Items That Are Specific For Your Study
Study Files - Administrative
Suggested Documents/Tabs That Should Be Maintained in the Administrative Binder/File
• _______ Contact Information
Guidelines for Handling and Reporting _______ Events
Procedures for Handling and Storing _______
Study _______ Information – Instructions for _______, _______, and _______
Drug _______, _______, and _______
_______ Report Forms – A _______ or _______ document designed to record all of the protocol required
information to be reported to the _______ on each trial subject.
• Sponsor Contact Information
Guidelines for Handling and Reporting Adverse Events
Procedures for Handling and Storing Laboratory Specimens
Study Drug Information – Instructions for storage, dispensing, and accounting
Drug Shipment, Dispensing, and Accounting
Case Report Forms – A printed or electronic document designed to record all of the protocol required
information to be reported to the sponsor on each trial subject.
• _______, Telephone Logs, Emails, and Meetings (_______/_______)
– Participants– Sponsor– IRB/Institution
_______ Copies of _______ Documents – Original documents, data, and records
Log of _______ Visits
Master Log of Study _______
Other Related Items That Are Specific For Your Study
• Correspondence, Telephone Logs, Emails, and Meetings (Signed/Dated) – Participants– Sponsor– IRB/Institution
Master Copies of Source Documents – Original documents, data, and records
Log of Monitor Visits
Master Log of Study Participants
Clinical File/Chart for Participant
A separate binder, file, or chart may be maintained for each participant
The following documents/tabs are recommended to be maintained for each participant
• Signed _______ Form
_______ Report Forms
_______ Documents
_______ Results
_______ Note or Record That the Personnel can use to record the events that occurred at _______ visit
• Signed Consent Form
Case Report Forms
Source Documents
Laboratory Results
Blue Note or Record That the Personnel can use to record the events that occurred at each visit
Other Related Items That Are Specific For Your Study 6
Suggestions for Maintaining Study Files/Binders/Charts
Within Each Tab/Category, File the Documents in _______ Date Order
File only ____ copy of each document in the proper place
• Unless otherwise specified by the _______ or ________
Within Each Tab/Category, File the Documents in Reverse Date Order File only 1 copy of each document in the proper place
• Unless otherwise specified by the sponsor or Study PI
Study Documents – Generally Required by Sponsors
This is a list of study documents that a sponsor requires before beginning a clinical trial
• Signed IRB Approved _______ and _______
Stamped IRB Approved _______ Form(s)
IRB _______ Letter
Signed and Completed Form FDA _______ (Drug Studies)
Signed _______ Letter (Device Studies)
_______ Forms for the PI, Co-Investigators, and Personnel Listed on the Form FDA _______
• Signed IRB Approved Protocol Narrative and Any Amendments
Stamped IRB Approved Consent Form(s)
IRB Approval Letter
Signed and Completed Form FDA 1572 (Drug Studies)
Signed Agreement Letter (Device Studies)
Financial Disclosure Forms for the PI, Co-Investigators, and Personnel Listed on the Form FDA 1572
_______ for the PI, Co-Investigators, and Personnel Listed on the Form FDA _______
Completion _______ for protocol specific training
Current Laboratory _______
Laboratory _______ Ranges
Signed Contract or Letter of _______
CVs for the PI, Co-Investigators, and Personnel Listed on the Form FDA 1572
Completion certificates for protocol specific training
Current Laboratory Certification
Laboratory Normal Ranges
Signed Contract or Letter of Agreement
Source documents are the forms that study team members record _____ and _____. This data is then transferred and reported onto the official _____ or _____which are submitted to the sponsor.
Purpose of Source Documents:• To confirm that the _____ exist• To verify that _____ in the CRFs are consistent with the information found in the source documents, which validates the _____ of the data
Source documents are the forms that study team members record data and observations. This data is then transferred and reported onto the official CRFs or e-CRFs which are submitted to the sponsor.
Purpose of Source Documents:• To confirm that the participants exist• To verify that data in the CRFs are consistent with the information found in
the source documents, which validates the integrity of the data
Source Documents should include the following information:
• Participant _____• _____ of all scheduled and unscheduled study visits• Signed and Dated _____ forms
• Verification of participant _____• _____ medications and the _____ for the medication
• Documentation of all _____ reported by the participant
• Appropriate _____ Documentation
• Participant Demographics• Dates of all scheduled and unscheduled study visits• Signed and Dated Informed Consent forms
• Verification of participant eligibility• Concomitant medications and the indications for the medication
• Documentation of all adverse events reported by the participant
• Appropriate HIPAA Documentation
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