Standard Operating Procedures

Title

Version

Effective Date

Review Date

R&D SOP01 Adverse Event & Safety Reporting for Clinical Trials of Investigational Medicinal Products (CTIMPs)

3.0

Oct 2020

Oct 2022

R&D SOP02 Obtaining Informed Consent for Clinical Trials of Investigational Medicinal Products (CTIMPs)

3.0

Oct 2020

Oct 2022

R&D SOP03 Maintaining Rater Blind for Clinical Trials of Investigational Medicinal Products (CTIMPs)

3.0

Oct 2020

Oct 2022

R&D SOP04 Emergency Telephone Calls Relating to Clinical Trials of Investigational Medicinal Products (CTIMPs)

3.0

Oct 2020

Oct 2022

R&D SOP05 Documenting Patient Research Participation in e-Health Records

2.0

Oct 2020

Oct 2022

R&D SOP06 Investigator Site File Maintenance for Clinical Trials of Investigational Medicinal Products (CTIMPs)

3.0

Oct 2020

Oct 2022

R&D SOP07 Use of Third Party IT Equipment for Clinical Trials

3.1

Oct 2020

Oct 2022

R&D SOP08 Archiving of Investigator Site Files for Clinical Trials

3.0

Oct 2020

Oct 2022

R&D SOP09 Clinical Research Associate Access to Trial Participant Data in the Trust Electronic Health Record System (Rio)

2.0

Oct 2020

Oct 2022

R&D SOP10 Serious Breaches of GCP or Protocol

1.0

Oct 2020

Oct 2022

R&D SOP11 Sponsorship of Research Studies

1.0

Nov 2020

Nov 2022

R&D SOP12 Commercial research income distribution and reinvestment model

1.0

Mar 2021

Mar 2023

 

Title

Version

Effective Date

Review Date

CT01 – Access to Room

4.1

Feb 2021

Feb 2023

CT02 – Staff Training

4.1

Feb 2021

Feb 2023

CT03 – Setup of New Trials

4.1

Feb 2021

Feb 2023

CT04 – Receipt of IMP

4.1

Feb 2021

Feb 2023

CT05 – Studies involving Controlled Drugs

4.1

Feb 2021

Feb 2023

CT06 – Storage of IMP

4.1

Feb 2021

Feb 2023

CT07 – Temperature Monitoring

4.1

Feb 2021

Feb 2023

CT08 – Completing Accountability Logs

4.1

Feb 2021

Feb 2023

CT09 – Dispensing and Checking Medication

4.1

Feb 2021

Feb 2023

CT10 – Handover of Medication

4.1

Feb 2021

Feb 2023

CT11 – Dealing with Medication Errors

4.1

Feb 2021

Feb 2023

CT12 – Expiry Date Checking

4.1

Feb 2021

Feb 2023

CT13 – Code Breaks

4.1

Feb 2021

Feb 2023

CT14 – Dispensed Prescriptions

4.1

Feb 2021

Feb 2023

CT15 – Archiving Pharmacy Documents

4.1

Feb 2021

Feb 2023

CT16 – Return and Disposal of IMP

4.1

Feb 2021

Feb 2023

CT17 – Writing SOPs

4.1

Feb 2021

Feb 2023

CT18 – Quarantine of Meds

4.1

Feb 2021

Feb 2023

CT19 – Recall of Meds

4.1

Feb 2021

Feb 2023

CT20 – Maintenance of Pharmacy Room

4.1

Feb 2021

Feb 2023

 

Guidance Documents

Title

Version

Effective Date

Review Date

R&D GD01 Safe Handling of Dry Ice

3.0

Sept 2020

Sept 2022

R&D GD02 Chief-Principal Investigator Responsibilities

3.0

Sept 2020

Sept 2022

R&D GD03 Post-Study Supply of Investigational Product

3.0

Sept 2020

Sept 2022

R&D GD04 Research Specific Functionality in Rio

1.0

Sept 2020

Sept 2022

R&D GD05 Managing Research Agreements & Contracts

1.0

Sept 2020

Sept 2022

R&D GD06 Management of Face to Face Visits During COVID-19

1.0

Nov 2020

Continuous review

R&D GD07 Management of TinyTag Temperature Loggers

1.0

Jan 2021

Jan 2023