Useful documents
Together with clinical care and teaching, research forms a vital part of the core activity of the Trust. In order to protect the dignity and rights of patients, the Research & Development Directorate is committed to ensuring that research performed at the Royal Devon is of the highest scientific and ethical standard.
Appropriate governance arrangements are in place, including policies and Standard Operating Procedures, in order to comply with Care Quality Commission standards, the Department of Health Research Governance Framework and the Medicines for Healthcare Regulatory Agency.
Guidelines
The following research guidelines are available:
SOPs
S01 Preparation of SOPs in R&D V7
S02 Submitting Protocol Amendments V4
S05 Notification of Serious Breaches of GCP or Study Protocol V6
S13 HRA and Other Regulatory Approvals V4
S21 Confirmation of Capacity and Capability V5
S26 Training for Researchers V4
S29 Letters of Access and the Research Passport V5
S31 Reporting required for sponsored CTIMPs V4
S39 Venepuncture And Heel Prick Sampling in Infants and Children V5
S42 Management of Research Samples V3
S45 Transportation of Temperature Sensitive Medicinal Products for Clinical Trials V4
S60 Electronic Transfer of Prescriptions to Trial Pharmacy V4
S63 Urgent Public Health Research V5
S67 Corrective and Preventive Action CAPA V2
S69 Preparation and administration of GMO Vaccines in Clinical Trials V1
Work Instructions
Templates and Forms
CRF Freezer Storage Application Form V6
FRM 20 Urgent Safety Measure Notification Form V3
CRN South West Peninsula Non Commercial Cost Attribution Template V1.6
FRM 46 Pregnancy on a Clinical Study Notification Form V3
FRM 47 Pregnancy on a Clinical Study Follow-up Form V3
FRM5 Notification of Serious Breach of GCP or Trial Protocol V3
FRM77 R&D Induction Program V4
TMP83 R&D Induction Checklist V2
NIHR Competency Framework for Research Delivery Staff V1
SWP Competency Framework Guidance on Bands and Levels V1
FRM62 Adverse Event Log Template V3
FRM63 Serious Adverse Event Log Template V3
FRM64 Source Document Tracking Log V4
Investigator Study Archive Form (checklist) V6
Notification non-substantial amendments form NHS Studies
Serious Breach of Good Clinical Practice or Trial Protocol
TMP13 Non-IMP TMF Contents Template Single Site V3
TMP17 Non-IMP ISF Contents Template V3
TMP19 Template Delegation Log V5
TMP22 Work Instruction Template V7
TMP30 Template Withdrawal Log V4
TMP31 Template Recruitment Randomisation Log IMP V5
TMP32 Template Screening Log V5
TMP36 Impact Form for Clinical Trials V9
TMP39 SOP & WI Training Log V4
TMP50 Template Recruitment Log Non IMP V5
TMP51 Regulated Trials TMF Contents Template Single Site V2
TMP56 Fridge or Freezer Temperature Log Template V3
TMP57 SIV & Training Record V3
TMP60 Template Training Record Review Log V2
TMP66 Study Modification Log V5
TMP70 Sponsored Study Responsibility Allocation Matrix non-interventional V3
TMP71 Sponsored Study Responsibility Allocation Matrix CTIMP V3
TMP72 Sponsored Study Responsibility Allocation Matrix Device V3
TMP73 Sponsored Study Responsibility Allocation Matrix Interventional V3
TMP74 Regulated Trials ISF Contents Template V2
TMP75 Non-IMP TMF Contents Template Multi Site V1
TMP76 Regulated Trials TMF Contents Template Multi Site V1
TMP85 Hosted Studies ISF Index Template
TMP86 Honorary Contract Log V1
TMP88 Sponsored Study Responsibility Allocation Matrix Non-Interventional CI Only V2