Queen Margaret Hospital

This section contains the Standard Operating Procedures (SOPs) issued by the Research & Development (R&D) Department.  All NHS Fife R&D Department SOPs should be used online, not in printed form.  Always check that you are using the most recent version.

When a new SOP is authorised, or when an existing SOP is revised, self directed training must be carried out by all staff to whom the SOP is relevant and this training documented in a training record. If you require assistance with SOP training please contact the R&D Department SOP Controller.

Where possible NHS Fife SOPs have been developed from an equivalent Tayside Medical Science Centre (TASC) SOP to ensure consistency with other partners in the East of Scotland node.  TASC SOPs are avialable via their website: http://www.ahspartnership.org.uk/tasc/for-researchers/sops.

The R&D Department SOP Controller (Julie Aitken, email: julieaitken2@nhs.net, Tel: 20306) will endeavour to notify staff via Dispatches and R&D Alerts that a new or revised document has been approved for implementation.  However, researchers should visit this page regularly to ensure that they are aware of and working to the latest SOPs, WIs and guidance documents relevant to their research.  If you wish to have your name added to the email alert system for SOP updates then please contact the SOP Controller. 

 

 

INDEX OF R&D DEPARTMENT SOPs

SOP No

Description

R&D SOP01

PREPARATION, APPROVAL AND REVIEW OF STANDARD OPERATING PROCEDURES

R&D SOP02

Withdrawn

R&D SOP03

ESTABLISHING AND MAINTAINING A SPONSOR FILE, TRIAL MASTER FILE OR AN INVESTIGATOR SITE FILE

R&D SOP04

Withdrawn

R&D SOP05

Withdrawn

R&D SOP06

SPONSOR APPROVAL OF RESEARCH PROJECTS INVOLVING HUMANS, THEIR TISSUE AND/OR DATA

R&D SOP07

 ASSESSMENT OF RISK

R&D SOP08

PREPARING AND SUBMITTING PROGRESS AND SAFETY REPORTS IN CTIMPs (CLINICAL TRIALS OF INVESTIGATIONAL MEDICINAL PRODUCTS) AND NON-CTIMPs

R&D SOP09

Withdrawn

R&D SOP10

CREATING AND MANAGING CLINICAL STUDY DATABASES

R&D SOP11

THE PROCESS OF LOCAL MANAGEMENT REVIEW AND APPROVAL OF ALL RESEARCH UNDERTAKEN IN NHS FIFE

R&D SOP12

QUALITY ASSURANCE AUDITS

SOP13(Fife)

COMPLETION OF DELEGATION OF RESPONSIBILITIES AND SIGNATURE LOG

SOP14(Fife)

OBTAINING INFORMED CONSENT

SOP15(Fife)

MANAGEMENT OF CLINICAL TRIAL MEDICINES

SOP16(Fife)

VISUAL VERIFICATION OF DATA ENTERED INTO A DATA MANAGEMENT SYSTEM

SOP17(Fife)

VERIFYING THE IDENTITY OF PARTICIPANTS IN CLINICAL RESEARCH

SOP18(Fife)

STATISTICAL ANALYSIS PLANS FOR CLINICAL TRIALS OF INVESTIGATIONAL MEDICINAL PRODUCTS

SOP19(Fife)

IDENTIFYING, RECORDING AND REPORTING ADVERSE EVENTS FOR CLINICAL TRIALS OF INVESTIGATIONAL MEDICINAL PRODUCTS (CTIMPs)

SOP20(Fife)

MANAGEMENT OF STUDY AMENDMENTS

SOP21(Fife)

PREPARING AND MAINTAING PAPER CASE REPORT FORMS (CRFs) FOR USE IN CLINICAL RESEARCH

SOP22(Fife)

MANAGEMENT OF BREACHES OF GCP OR THE STUDY PROTOCOL FOR CLINICAL RESEARCH

SOP23(Fife)

PREPARATION, APPROVAL AND REVIEW OF POLICIES FOR NHS FIFE R&D DEPARTMENT

SOP24(Fife)

RESEARCH PASSPORTS, HONORARY RESEARCH CONTRACTS, LETTERS OF ACCESS AND OTHER PROCESSES FOR EXTERNAL RESEARCHERS

SOP25(Fife)

COLLECTION, PROCESSING, STORAGE AND TRANSPORTATION OF BIOLOGICAL SAMPLES

SOP26(Fife)

DATA MANAGEMENT TO GOOD CLINICAL PRACTICE STANDARDS

SOP27(Fife)

PREPARING AND PARTICIPATING IN A MEDICINES AND HEALTHCARE PRODUCTS REGULATION AGENCY (MHRA) INSPECTION

SOP28(Fife)

STUDY SET-UP INCLUDING CLINICAL TRIALS OF INVESTIGATIONAL MEDICINAL PRODUCTS

SOP29(Fife)

PREPARATION OF AN ANALYTICAL PLAN FOR LABORATORIES ASSOCIATED WITH CLINICAL RESEARCH

SOP30(Fife)

MONITORING RESEARCH (CLINICAL TRIALS OF INVESTIGATIONAL MEDICINAL PRODUCTS, CTIMPS AND NON-CTIMPs

SOP31(Fife)

IDENTIFYING, RECORDING AND REPORTING ADVERSE EVENTS FOR RESEARCH OTHER THAN CLINICAL TRIALS OF INVESTIGATIONAL MEDICINAL PRODUCTS (CTIMPs) OR REGULATED CLINICAL INVESTIGATIONS OF MEDICAL DEVICES

SOP32(Fife)

IDENTIFYING, RECORDING AND REPORTING ADVERSE EVENTS FOR CLINICAL INVESTIGATIONS OF MEDICAL DEVICES

SOP33(Fife)

CLOSURE OF CLINICAL RESEARCH STUDIES

SOP34(Fife)

SELECTING SITES & INVESTIGATORS

SOP35(Fife)

ARCHIVING CLINICAL RESEARCH DATA (INCLUDING FOR CLINICAL TRIALS OF INVESTIGATIONAL MEDICINAL PRODUCTS)

SOP36(Fife)

LOCKING CLINICAL STUDY DATABASES

SOP37(Fife)

DATA MANAGEMENT IN ALL CLINICAL RESEARCH INCLUDING TRIALS OF INVESTIGATIONAL MEDICINAL PRODUCTS USING EXCEL

SOP38(Fife) COMPLAINTS HANDLING

 

For more information contact

Julie Aitken, R&D Trials Facilitator 
Contact Julie Aitken online
By Post: NHS Fife, Queen Margaret Hospital Whitefield Road Dunfermline Fife KY12 0SU

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