Research Policies, Standard Operating Procedures (SOPs ...



Research Policies, Standard Operating Procedures (SOPs) and GCP Training RecordGuidance for Use:We have produced this list to support your training records, a complete list will be issued with every new SOP or amendment. Evidence of training in our SOPS is required for all clinical researchers, but you do not have to use this template.You should keep your own evidence records or alternatively you may have a central file containing the most up to date policies within your department. You may create your own log or print and sign the training records at the back of each SOP.All final controlled versions and their supporting templates are online at: Name: ______________________________________Role:______________________________________Policies and SOP TrainingNumberVersion(Sign and date for each version you are trained on)PHT - Income Distribution from Commercial Research ActivityPlease note: Evidence of training in this policy is not a requirement but is recommended. N/AV4.0, Nov 2011Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________Clinical Research Safety Monitoring PolicyPHT/RDPOLICY/002V1.0, 08/11/12Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________Policies and SOP TrainingNumberVersion(Sign and date for each version you are trained on)Reporting Serious Breaches in Clinical ResearchPHT/RDSOP/002V1.0, 04/05/12Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________Monitoring Research Studies Sponsored by PHTPHT/RDSOP/003V2.0, 16/12/19Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________Recruiting & Consenting Patients into Clinical Research PHT/RDSOP/005V1.0, 04/05/12Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________Reporting Urgent Safety Measures in Clinical ResearchPHT/RDSOP/006V1.0, 04/05/12Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________Recording, Assessing & Reporting Adverse Events in Clinical ResearchPHT/RDSOP/007V1.0, 08/11/12Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________Establishing and Maintaining a TMF or ISFPHT/RDSOP/009V1.0, 08/11/12Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________Preparation and Procedure to ArchivePHT/RDSOP/011V1.0, 18/11/14Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________Delegation of Roles & ResponsibilitiesPHT/RDSOP/012V1.0, 18/11/14Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________Data ManagementPHT/RDSOP/013V1.0, 26/04/16Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________Randomisation and BlindingPHT/RDSOP/014V1.0, 26/04/16Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________Protocol DevelopmentPHT/RDSOP/015V1.0, 26/04/16Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________Management of Amendments to PHT Sponsored StudiesPHT/RDSOP/016V1.0, 05/10/18Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________Creation of Crib Sheets for Clinical Data CollectionPHT/RDSOP/017V1.0, 05/08/16Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________Risk assessment of Studies Sponsored by PHTPHT/RDSOP/018V1.0, 16/12/19Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________Developing a Monitoring Plan for Studies Sponsored by PHTPHT/RDSOP/019V1.0, 16/12/19Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________Initiating and managing CAPA plansPHT/RDSOP/020V1.0, 16/12/19Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________V___, __/__/__Sign:____________Date:____________GCP Training Course Type(Tick the appropriate box)Date of CertificateRefresher Due (Two years from date of last training)SignatureIntroduction to GCP Refresher Face to face Online Introduction to GCP Refresher Face to face Online Introduction to GCP Refresher Face to face Online Introduction to GCP Refresher Face to face Online Introduction to GCP Refresher Face to face Online Introduction to GCP Refresher Face to face Online Introduction to GCP Refresher Face to face Online Introduction to GCP Refresher Face to face Online ................
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