Document Code

 Document Name

1

CRC-QMS-001

Quality Policy Statement

2

CRC-QMS-002

Standard Operating Procedure for the Preparation, Approval, Distribution, Review, Revision and Withdrawal of Standard Operating Procedures (SOPs)

3

CRC-QMS-003

Quality Management System at the UCD CRC

4

CRC-STM-001

Standard Operating Procedure for Application for access to the CRC and the Evaluation of Applications

5

CRC-STM-002

Sponsorship SOP

6

CRC-Policy-001

Biobank Policy

7

CRC-Policy-002

Medical Emergency Policy

8

CRC-Policy-003

Information Technology Policy

9

CRC-Policy-004

Laboratory Policy

10

CRC-Policy-008

Core Lab General Operating Information

11

CRC-Policy-009

Pharmacovigilance - Safety Reporting

12

CRC-Safey-001

Safety Guidelines for Collection and Handling of Biological Materials

13

CRC-Safety-004

Safety Guidelines for Disposal of Sharps

14

CRC-Safety-005

Safety Guidelines for Handling Chemical Hazards

15

CRC-Safety-006

Safety Guidelines for Handling Dry Ice

16

CRC-Safety-007

Safety Guidelines for Handling Liquid Nitrogen

17

CRC-Safety-008

Disposal of Hazardous Laboratory Waste

18

CRC-Safety-009

Handling of Chemical and Biological Spills

19

CRC-Reg-001

Ethics Approval Required for Clinical Research Studies at the CRC

20

CRC-Reg-002

Regulatory Submissions for Clinical Trials

21

CRC-Reg-004

Document Control & Archiving of Clinical Trial Documents

22

CRC-Reg-005

Safety Reporting for Externally Sponsored Studies

23

CRC-Reg-006

Safety Reporting for UCD Sponsored Clinical Trials

24

CRC-Reg-007

Management of Investigational Medicinal Product (IMP) in Clinical Trials

25

CRC-Reg-008

Establishing & Maintaining Training Record Files in UCD CRC

26

CRC-Reg-009

Clinical Trial Monitoring

27

CRC-Reg-010

Screening & Patient Enrolment

28

CRC-Reg-011

Study Conduct: Compliance & Management of Deviations

29

CRC-Reg-012

Study Task Delegation & Staff Transition

30

CRC-Reg-013

Clinical Trials Stopping Policy

31

CRC-Reg-014

UCD Clinical Trial Sponsorship

32

CRC-Lab-001

Serum Processing Whole Blood

33

CRC-Lab-005

Tissue Preparation

34

CRC-Lab-007

Preparation of PBMCs From Whole Blood

35

CRC-Lab-008

Processing of Urine for Biochemical & Proteomic Analysis

36

CRC-Lab-009

Processing of Faeces and Faeces Extract

37

CRC-Lab-010

Core Lab Sample Receipt and Storage

38

CRC-Lab-011

Core Lab FAM (Familiarisation) Testing

39

CRC-Lab-012

Core Lab Testing

40

CRC-Lab-013

Core Lab Data Handling and Storage

41

CRC-Bio-001

Sample Handling

42

CRC-Bio-005

Use of Patient Kits

43

CRC-Bio-006

Biobank Facility Monitoring

44

CRC-WI-001

Adult Height & Weight Measurement

45

CRC-WI- 002

Recording a 12 lead ECG

46

CRC-WI- 003

Measurement of Blood Pressure & Pulse

47

CRC-WI- 004

Obtaining Blood Samples From a Cannula

48

CRC-WI- 005

Recording a Temperature Using the GENIUS 2 Thermometer

49

CRC-WI- 006

Urine Pregnancy Testing

50

CRC-WI- 007

Courier Packages to and From UCD CRC

51

CRC-WI- 008

Security in UCD CRC

52

CRC-WI- 009

Archiving Procedure

53

CRC-WI- 013

Work Instruction for Emergency Transfer and Communication with the University

Hospital

54

CRC-WI- 016

Rota Responsibilities

55

CRC-WI- 017

Process for Taking Informed Consent

56

CRC-WI-019

UCD CRC IMP Monitoring Instructions (T-Scan system)

57

CRC-Clin-001

Blood Collection by Venipuncture

58

CRC-Clin-002

Saliva Collection

59

CRC-Clin-003

Midstream, 24-hour and Catheter Urine Collection

60

CRC-CDM-001

Computer Systems Validation

61

CRC-CDM-002

Case Report Form (CRF) & Database Development

62

CRC-CDM-003

REDCap User Account & Access Management

63

CRC-CDM-004

REDCap Data Management & Database Lock