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	08/28/2012
•	Model CTA Outline	09/21/2011
•	Model Confidential Disclosure Agreement - Unilateral: For use by a sponsor when disclosing confidential information to a site prior to a study. More information	03/02/2013
•	Budget Template	03/02/2013
•	Legal Glossary	09/21/2011

Forms
•	Conference Report: Document is protected with code "MAGI".	11/25/2010
•	IRB Site Questionnaire: Document is protected with code "MAGI". More information	10/20/2012
•	Delegation of Authority Log: Document is protected with code "MAGI".	10/23/2010
•	Financial Disclosure Form: Document is protected with code "MAGI".	10/23/2010
•	HIPAA Authorization Form: A short form written at the seventh-grade reading level. More information	01/11/2012
•	Investigator Biography Form: Document is protected with code "MAGI".	10/23/2010
•	Prescreening Log: Document is protected with code "MAGI". See Screening & Enrollment Log.	10/23/2010
•	Screening & Enrollment Log: Document is protected with code "MAGI". See Prescreening Log.	10/23/2010
•	Study Startup Sheet: Document is protected with code "MAGI".	10/23/2010
•	Subject Contact Information Form: Document is protected with code "MAGI".	10/23/2010
•	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.	10/23/2010
•	Appointment Card: Document is protected with code "MAGI".	03/02/2013
•	Protocol Deviation Report: Document is protected with code "MAGI".	05/10/2012
•	Protocol Deviation Log: Document is protected with code "MAGI".	05/10/2012
•	Unanticipated Problem Report: Document is protected with code "MAGI". More information	10/23/2010
•	Note to File: Document is protected with code "MAGI".	05/10/2012
•	CAPA Plan: Document is protected with code "MAGI".	05/10/2012
•	Study Participant Feedback Form: Document is protected with code "MAGI".	10/20/2012
•	Site Monitor Feedback Form: Document is protected with code "MAGI".	10/20/2012
•	Sponsor Report Card: Document is protected with code "MAGI". More information	05/10/2012
•	Lessons Learned Report: Document is protected with code "MAGI".	02/15/2012

Form Letters
•	FDA: Electronic Signatures	10/03/2010
•	IRB: Document Review Not Meeting	10/03/2010
•	IRB: Document Review Meeting	10/03/2010
•	IRB: PI Approval	10/03/2010
•	IRB: Protocol Review	10/03/2010
•	IRB: Protocol Amendment	10/03/2010
•	IRB: Study Closeout	10/03/2010
•	IRB: Withdrawal	10/03/2010
•	Misc: Subject Travel	10/03/2010
•	Physician: Billing Request	10/03/2010
•	Physician: Compensation	10/03/2010
•	Physician: Medical Records	10/03/2010
•	Physician: Medical Records from Hospital	10/03/2010
•	Physician: Patient Summary Report	10/03/2010
•	Physician: Referral Inquiry	10/03/2010
•	Physician: Referral Missing Items	10/03/2010
•	Physician: Referral Thank You	10/03/2010
•	Physician: Subject Enrollment	10/03/2010
•	Pharmacist: Subject Enrollment	03/23/2011
•	Sponsor: Final IRB Report	10/03/2010
•	Sponsor: Monitoring Report Response	07/31/2011
•	Sponsor: Regulatory Documents	10/03/2010
•	Sponsor: Regulatory Documents Updated	10/03/2010
•	Sponsor: Replacement Monitor	10/03/2010
•	Sponsor: SAE Report	10/03/2010
•	Sponsor: Treatment Authorization	10/03/2010
•	Sponsor: Unblinding	10/03/2010
•	Sponsor: Charges Prior to CTA	10/03/2010
•	Subject: Consent	10/03/2010
•	Subject: Consent Visit Reminder	10/03/2010
•	Subject: Ineligible	10/03/2010
•	Subject: Lab Report	10/03/2010
•	Subject: Missed Visit	10/03/2010
•	Subject: Study Results	10/03/2010
•	Subject: Thank You	10/03/2010
•	Subject: Treatment Notification	10/03/2010
•	Subject: Visit Reminder	10/03/2010
•	Subject: Visit Screening Reminder	10/03/2010

Coding Systems
•	Protocol Deviation & Violation (PDV) Codes: Coding system with over 120 circumstances that may qualify as a protocol violation or deviation. More information	01/11/2012
•	Clinical Research Terminology (CRT) Codes: Coding system with over 200 investigative site research activities that do not have CPT codes. More information	02/25/2013
•	Clinical Research Service (CRS) Codes: Coding system with over 150 contract research organization (CRO) activities.	05/10/2012

Other
•	Protocol Evaluation Questions: Questions for evaluating protocol feasibility. More information	01/11/2012
•	Site Evaluation Questions: Questions for evaluating sites for a study. More information	01/11/2012
•	Research Site Code of Ethics: Model code of ethics for a research site.	10/27/2009

Please send us your questions, comments and suggestions.