Model Agreements NHSL accepts the use of all of the published model clinical trial agreements without requesting any revision or insertion of additional wording. The following model clinical trial agreements are currently available. Parties using the following model clinical trial agreements must ensure they use the current versions as published online: Model Agreement Parties Description mCTA (model clinical trial NHSL and Used for commercially agreement) Sponsor Company sponsored CTIMP studies mCRO CTA NHSL, Used for commercially Clinical Research sponsored CTIMP studies Organisation (CRO) and that involve additional Sponsor Company input from a CRO mCIA (model clinical NHSL and Used for commercially investigation agreement) Sponsor Company sponsored device studies mCRO CIA NHSL, Used for commercially Clinical Research sponsored device studies Organisation (CRO) and that involve additional Sponsor Company input from a CRO mNCA (model NHSL and Used for academic and commercial agreement) Sponsor non-commercial studies (this model may be used sponsored by charities, as a tri-partite agreement academic institutions and where 2 bodies are NHS organisations Information Added to Model Agreements All model agreements will be provided by the sponsor as the template document populated with sponsor and study details. The Principal R&D Manager, or designee, will review the proposed agreement and provide the following information: Blank Information to be Added Board name, designation and Lothian Health Board, constituted headquarters address pursuant to the National Health Service (Scotland) Act 1978 (as amended) and having its headquarters at Waverley Gate, 2-4 Waterloo Place, Edinburgh, EH1 3EG, UK (only add UK if the sponsor is out with the UK) Principal Investigator (PI) details The fully name and title of the individual who will be the local PI for the study in NHSL Signatory on behalf of NHSL Should be left blank where possible
Model Agreements NHSL accepts the use of all of the published model clinical trial agreements without requesting any revision or insertion of additional wording. The following model clinical trial agreements are currently available. Parties using the following model clinical trial agreements must ensure they use the current versions as published online: Model Agreement Parties Description mCTA (model clinical trial agreement) NHSL and Sponsor Company Used for commercially sponsored CTIMP studies mCRO CTA NHSL, Clinical Research Organisation (CRO) and Sponsor Company Used for commercially sponsored CTIMP studies that involve additional input from a CRO mCIA (model clinical investigation agreement) NHSL and Sponsor Company Used for commercially sponsored device studies mCRO CIA NHSL, Clinical Research Organisation (CRO) and Sponsor Company Used for commercially sponsored device studies that involve additional input from a CRO mNCA (model agreement) NHSL and Sponsor (this model may be used as a tri-partite agreement where 2 bodies are Used for academic and non-commercial studies sponsored by charities, academic institutions and NHS organisations Information Added to Model Agreements All model agreements will be provided by the sponsor as the template document populated with sponsor and study details. The Principal R&D Manager, or designee, will review the proposed agreement and provide the following information: Blank Information to be Added Board name, designation and headquarters address Lothian Health Board, constituted pursuant to the National Health Service (Scotland) Act 1978 (as amended) and having its headquarters at Waverley Gate, 2-4 Waterloo Place, Edinburgh, EH1 3EG, UK (only add UK if the sponsor is out with the UK) Principal Investigator (PI) details The fully name and title of the individual who will be the local PI for the study in NHSL Signatory on behalf of NHSL Should be left blank where possible commercial
GS001-W01%20Agreement%20Preparation%20-%20Host%20v2.0.docx