MAGI - Best Practice Standards

Best Practice Standards

MAGI members: click here to download these documents.

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MAGI grants its members the free right to use the following standards within their entity and with business partners, provided the copyright notice is included without modification. Two documents are available to the general public: Model Clinical Trial Agreement (abbreviated, obsolete version) and Budget Template (non-editable version).

Contracts & Budgets (See also State & International Requirements for Clinical Trial Agreements)
•	Model Clinical Trial Agreement	11/15/2011
•	Model CTA Outline	09/20/2011
•	Confidential Disclosure Agreement - Unilateral: For use by a sponsor when disclosing confidential information to a site prior to a study. More information	11/15/2011
•	Budget Template	09/20/2011
•	Legal Glossary	09/20/2011

Forms
•	Conference Report: Document is protected with code "MAGI".	11/22/2010
•	Delegation of Authority Log: Document is protected with code "MAGI".	10/19/2010
•	Financial Disclosure Form: Document is protected with code "MAGI".	10/19/2010
•	HIPAA Authorization Form: A short form written at the seventh-grade reading level. More information	11/24/2011
•	Investigator Biography Form: Document is protected with code "MAGI".	10/19/2010
•	Lessons Learned Report: Document is protected with code "MAGI".	09/20/2011
•	Prescreening Log: Document is protected with code "MAGI". See Screening & Enrollment Log.	10/19/2010
•	Screening & Enrollment Log: Document is protected with code "MAGI". See Prescreening Log.	10/19/2010
•	Study Startup Sheet: Document is protected with code "MAGI".	10/19/2010
•	Subject Contact Information Form: Document is protected with code "MAGI".	10/19/2010
•	Unanticipated Problem Report: Document is protected with code "MAGI". More information	10/19/2010
•	Visit Scheduler: Document is protected with code "MAGI". It includes two versions, one for use on a computer and one to print out for hardcopy use.	10/22/2010

Form Letters
•	FDA: Electronic Signatures	09/06/2010
•	IRB: Document Review Not Meeting	09/06/2010
•	IRB: Document Review Meeting	09/06/2010
•	IRB: PI Approval	09/06/2010
•	IRB: Protocol Review	09/06/2010
•	IRB: Protocol Amendment	09/06/2010
•	IRB: Study Closeout	09/06/2010
•	IRB: Withdrawal	09/06/2010
•	Misc: Subject Travel	09/06/2010
•	Physician: Billing Request	09/06/2010
•	Physician: Compensation	09/06/2010
•	Physician: Medical Records	09/06/2010
•	Physician: Medical Records from Hospital	09/06/2010
•	Physician: Patient Summary Report	09/06/2010
•	Physician: Referral Inquiry	09/06/2010
•	Physician: Referral Missing Items	09/06/2010
•	Physician: Referral Thank You	09/06/2010
•	Physician: Subject Enrollment	09/06/2010
•	Pharmacist: Subject Enrollment	03/11/2011
•	Sponsor: Final IRB Report	09/06/2010
•	Sponsor: Monitoring Report Response	07/10/2011
•	Sponsor: Regulatory Documents	09/06/2010
•	Sponsor: Regulatory Documents Updated	09/06/2010
•	Sponsor: Replacement Monitor	09/06/2010
•	Sponsor: SAE Report	09/06/2010
•	Sponsor: Treatment Authorization	09/06/2010
•	Sponsor: Unblinding	09/06/2010
•	Sponsor: Charges Prior to CTA	09/06/2010
•	Subject: Consent	09/06/2010
•	Subject: Consent Visit Reminder	09/06/2010
•	Subject: Ineligible	09/06/2010
•	Subject: Lab Report	09/06/2010
•	Subject: Missed Visit	09/06/2010
•	Subject: Study Results	09/06/2010
•	Subject: Thank You	09/06/2010
•	Subject: Treatment Notification	09/06/2010
•	Subject: Visit Reminder	09/06/2010
•	Subject: Visit Screening Reminder	09/06/2010

Coding Systems
•	Protocol Deviation & Violation (PDV) Codes: Coding system with over 120 circumstances that may qualify as a protocol violation or deviation. More information	11/24/2011
•	Clinical Research Terminology (CRT) Codes: Coding system with over 200 investigative site research activities that do not have CPT codes. More information	11/24/2011
•	Clinical Research Service (CRS) Codes: Coding system with over 150 contract research organization (CRO) activities.	11/24/2011

Other
•	Protocol Evaluation Questions: Questions for evaluating protocol feasibility. More information	11/24/2011
•	Site Evaluation Questions: Questions for evaluating sites for a study. More information	11/24/2011
•	Research Site Code of Ethics: Model code of ethics for a research site.	10/21/2009

Please send us your questions, comments and suggestions.