MAGI - MAGI Regional Clinical Trial Agreement Requirements

MAGI Regional Clinical Trial Agreement Requirements

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France
Requirement:

Laboratory may request/require separate bipartite CTA (Laboratory Manager and Sponsor/CRO) even if it is part of a hospital site.

Source:

Anonymous

France
Requirement:

For private sites, usually bipartite CTA (PI and Sponsor/CRO), and sometimes? tripartite CTA (PI, PI's Association, and Sponsor/CRO). Association's president/treasurer/secretary signs.

Source:

Anonymous

France
Requirement:

Hospital pharmacy may request/require? a separate agreement if Sponsor/CRO requires destruction of unused study drug.

Source:

Anonymous

France
Requirement:

Hospitals require tripartite CTA (PI, hospital and sponsor/CRO) or 4-party CTA, including hospital association

Source:

Anonymous

France
Requirement:

Hospitals may request/require? a separate? tripartite CTA (PI, Institution and Sponsor/CRO) to cover pharmacy, lab, study-specific exam (e.g., X-Ray) and/or administrative costs.

Source:

Anonymous

Germany
Requirement:

If CTA is between site and CRO, some sites request/require? additional short CTA with Sponsor.

Source:

Anonymous

Germany
Requirement:

Separate agreement with site/hospital/institution. Separate agreement with PI. Separate agreement with pharmacy, even if in hospital. Sometimes separate ageement with lead PI in Germany. Sometimes with study nurse.

Source:

Anonymous

Germany
Requirement:

Single CTA. Institution signs. Principal Investigator sometimes signs.

Source:

Anonymous

Greece
Requirement:

CTA with institution. No separate investigator or pharmacy agreement required.

Source:

Anonymous

India
Requirement:

Single CTA. Institution sometimes signs. Principal Investigator sometimes signs.

Source:

Anonymous

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