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 |