Laboratory Medicine Checklist for Approving Research Studies

Laboratory Medicine Checklist for Approving Research Studies

Sheffield Teaching Hospitals NHS Foundation Trust Procedure No. LMDMO-R02

Directorate of Laboratory Medicine Revision No. 1.1

Department: Directorate Management Office Page 1 of 10

Section: Research


Please read guidance notes before completing this form.

Section 1
Completed by Researcher / Core Information
STH Number
Study Title
(Abbreviated Title/Acronym)
Recruitment Target at STH
Funding / Commercial or Non Commercial
Protocol Revision Number:
Amendments – any STH amendment requiring additional work will require Lab Directorate Approval via an RMS task. / Increase in work already agreed: / Y / N
New tests required: / Y / N
Protocol Information:
State the pages in your protocol that summarise the tests required and frequency of sampling. / Laboratory Tests / Schedule of Tests/Visits
Sample Analysis:
State which STH site the samples will be sent to. / NGH, RHH or BOTH
Section 2
Completed by Researcher / Laboratory Medicine Test Request
Only state the Tests Requiring Analysis at STH Lab Med:
1. Lists all the tests required at STH(see appendix12 for common Chemistry profile & test information).
2. State the number of tests per patient regarded as being Standard Care and the number that are Research.
3. For each test regarded as a Research request, state the total number of research tests during the study if you achieve the recruitment target.
4. State whether samples will be sent to Labs in Real Time (on the day of collection) or as a Batch (if batch analysis is required state the maximum number of samples). / Tests Required / Standard Care
(per patient) / Research
(per patient) / Total Number of
Research samplesper test / Real Time or Batch Analysis
( R or B )
Batch Analysis – for the Lab to take forward any such requests the study team will need to agree to our Batch Analysis Worksheet terms and conditions(see guidance p6 & appendix 3). / Yes / No / Not requested
HISTOPATHOLOGY - If YES, complete Section 3; if No, Researchers go to section 5 / Yes / No
Section 3
Completed by Researcher
(see guidance notes p6&7) / Histopathology
1. Has a member of the histopathology team been contacted about this trial (Consultant or Biomedical Scientist)? / Yes / No / If yes please give details of who has been contacted.
2. Please give a brief description of the overall histology element of the study (include numbers of samples per patient)
3. What services will be required from STH Histopathology?
4. If blocks or slides are to be requested to leave the dept please give a description of intended use.
5. How long will the block/slide be out of our storage for?
Section 4
Completed by Lab Med:
STH - / Laboratory Tests & Histology Costs
The prices quoted for this work is subject to an annual increase which would be in accordance with NHS inflation costs; and for commercial studies, subject to revisions made to the NIHR ‘Industry Costing Template’.
LABORATORY TESTS: / Y / N / Laboratory Test Availability: / Date: / By:
HISTOLOGY: / Y / N / Histology Work Task Availability: / Date: / By:
Funding (Commercial or Non-commercial) / Administration/Set-up Cost (£)
Laboratory Discipline / Laboratory Tests / Able to Provide Test (Y/N) / Cost per Sample (£) / Lab Analysis Real or Batch
Study Request for Batch Analysis Sample Handling / Agreement to Lab Conditions / Y / N / Partial / NR / Fee if applicable
HISTOLOGY / Requirements for: / Research Cost Per Patient (£)
Costs Completed: / Date: By:
Laboratory Medicine Directorate Approval will be required and this will only be given via an RMS task set up by the Research Department
Section 5
Completed by Researcher / Research Approval & Information Required for Research Study Labels and the Reporting of Results
Research Approval / Laboratory Medicine must be informed of Research Authorisation via the RMS notification system
The study team should contact labs prior to starting the study.
Medic/ Address / Location:
For the reporting of results / Medic / Consultant / Address / Location
Clinical Query
State a contact for lab staff to use in the event of an urgent clinical query / Name / Telephone Ext / Bleep / Location
Sample Query
State a contact for lab staff to use in the event of a sample query / Name / Telephone Ext / Location
If Batch Analysis has been requested, and coded sample ID’s are to be used, please give an example of the format of your numbering system:
Results Available Electronically on ICE?
If ‘YES’ the results will be viewable to all users of ICE.
Results will only go through to ICE if there is a hospital number stated on the request form, or matched with that person. Where the ‘recruit’ does not have a hospital number you will need to review the hardcopy reports. / YES / NO

Guidance on completing the form

The Researcher should complete all the shaded boxes where directed. Section 4 is for Lab Med only. Where the word ‘researcher’ is used – this can be the ‘researcher’ or the ‘research nurse’ running the study; whoever is the most appropriate person.

Please insert additional lines where required. Where there is a YES/NO option please delete or highlight as appropriate. Where there is a letter in (brackets), please type that letter in the following boxes as appropriate.

A completed copy of this form, together with the full protocol and the lab manual (if appropriate) should be available in the RMS/Alfresco system or sent to:

Christine Burgin –

NB. When agreement is given to provide a laboratory support service for research work that service will be as described on this form and not to what may otherwise be written in the protocol

For any advice on completing the Histology section of this form please contact Cathryn Leng, - or 0114 2261380

Whilst it is frequently useful for contact to have been made with a member of staff from the histology team in the early stages of setting up a trial it should be noted that if a member of the histopathology team either medical or technical has been approached prior to this form being completed and any approval has been given, this approval does not necessarily represent the approval of the department and so the department is under no obligation to uphold any agreements which have been made. Agreements can only be made once the full information for a trial has been formally submitted and approved by the lab.

Section 1- Core Information


First Contact – The core information and a clear identification of thetype and frequency of laboratory testing requirements are essential to ensure that workload and any capacity issues can be assessed as soon as possible.

Amendments – The study team should only contact Labs about amendments that require the additional use of our services, and which therefore will need to receive our Directorate Approval via the RMS system:

1. Where an amendment is the first contact that Labs have received about a study, the study will need to go through our full set-up process to obtain approval. After finance approval and research authorisation this will require the laboratory to create a study specific code and study labels; therefore the study must allow time for this to take place.

2. Where there is an amendment to a study, which requires an increase in workload to research tests already set-up with Lab Med, approval is required but no additional lab set-up is required.

3. Where there is an amendment to a study already set-up with Lab Med but which requires new tests, approval is required and the laboratory will need to create additional study labels.

Section 2- Laboratory Tests Required


1. Only list the tests that are required at STH.State whether the test is regarded asStandard Care and/or Research; and whether the samples are required in real time (on the day of collection) or in batches (stored by the study). This is necessary in order to identify costs and capacity issues.

2. For commonly requested Chemistry tests: where your test combination matches the General Chemistry profiles (appendix1) use our profile name otherwise please list all tests required. Appendix 1&2 shows the common automated Chemistry profiles and tests available.

3. Batch Analysis agreement is required where the batch analysis of samples stored by the study team is requested. Worksheet examples will be supplied to the study team as required (see appendix 3). The study team is being asked to agree to:

a)complete our Batch Analysis worksheet (mandatory);

b)be prepared to put their samples into ‘tubes’ supplied by the laboratory;

c)label the ‘tubes’ with the patient ID, and barcode the tubes where barcodes are supplied by the laboratory;

d)rack the samples in the order as stated in the worksheet (mandatory);

e)liaise with the department concerned with regards to making the final arrangement for sample receipt (mandatory).

4. Where a study is unable to prepare their samples as requested (b & c) an additional sampling handling fee will be charged.

Section 3 - Histopathology


Please give the number of patients at the STH site and each participating centre to include the number of samples for each patient i.e. will they have original tumour and recurrences to be used for trial purposes. Give concise information about what will be required of the department for this study for example information about the following:-

1. Sampling of fresh tissue?

2. Processing of tissue taken for trial purposes only?

3. Sectioning of blocks taken for trial purposes only?

4. Archived or routine blocks to be sent away to trial coordinating centre?

5. New slides being cut for trial purposes?

6. Archive slides to be sent for central review?

7. Reports being sent to trial coordinating centre?

8. Reporting of tissue being sampled for trial purposes only?

9. Will the blocks to be used in this study need to be selected by our pathologists or will they be selected by pathologists working on the study?

Please give details of the activities to be performed using the blocks requested,

1. Will cores be removed for tissue micro array construction?

2. How many slides will be cut from each block?

3. At what thickness?

4. Details of where the blocks are to be sent

For the release of tumour blocks from Sheffield Teaching Hospitals NHS FT Pathology Departments Diagnostic Archive the Sponsor must agree to the following terms:

  • Where the block is unique i.e. where it is the only block to contain the diagnostic condition:

1)Return of tissue blocks with in three months of receipt.

2)Not to exhaust the tissue blocks of diagnostically relevant material.

3)Not to request tissue blocks and slides at the same time.

  • Where the block is non-unique:

1)Return of tissue blocks with in one year of receipt

2)Not to exhaust the tissue blocks of diagnostically relevant material.

3)Not to request tissue blocks and slides at the same time.

The uniqueness of a block will be determined on a patient by patient basis at the time of block release.

Please state now that you will be able to comply with a three month turnaround, if you are unable to comply unique blocks will not be released.

Section 4- Laboratory Costs

Laboratory Medicine

This identifies the Laboratory tests and Histology work that can be performed at STH, the costs and the ‘frequency’ of analysis by the Labs (check with labs to confirm).

Please note any comments made on this page about the Laboratory tests or Histology.

Section 5- Notification of Research Authorisation & Procedure Prior to Sending Samples to the Laboratory


For studies requiring the analysis of ‘research’ samples, arrangements must be made with C. Burgin at least two weeks prior to the start of samples being sent to the laboratory. All research samples must have a study label on the form that has been generated by Laboratory Medicine. The information required in this section is necessary in order to set up IT conditions for the study code/labels, to ensure the results are reported to the correct location, and so activity can be monitored.

Appendix 1 – Common Chemistry Profiles Available at STH

Name of Test / Profile Name
Urea & Electrolytes (UE) / Full Profile (FP) / Liver Function (LFT) / Bone / Renal
Alanine Transaminase / ALT
Albumin / ALB / ALB / ALB / ALB
Alkaline Phosphatase / ALP / ALP / ALP / ALP
Aspartate Transaminase / AST / AST
Bicarbonate / BIC
Calcium / CA / CA / CA
Corrected Calcium / CCA / CCA / CCA
Creatinine / CR / CR / CR
Globulin / GLOB / GLOB / GLOB / GLOB
Phosphate / PO4 / PO4 / PO4
Potassium / K / K / K
Sodium / NA / NA / NA
Total Bilirubin / BIL / BIL / BIL
Total Protein / TP / TP / TP / TP
Urea / UR / UR / UR
Lipid Profiles / LIP / LP (Fasting) / LP (Not fasting or unknown)
Cholesterol / X / X / X
Triglycerides / X / X / X
HDL / X / X
TC/HDL Ratio / X / X

Where your test requesting pattern matches these profiles please write the profile name in Section 2. Any other combinations or additional tests should be identified individually. Study specific test profiles can be created to accommodate your requirements providing that the department offers those tests.

Appendix 2 –Commonly Requested Automated Chemistry Tests

Test Abbreviation / Test / Test Abbreviation / Test
ALB / Albumin / GL / Glucose
ALC / Alcohol / HDL / High Density Lipoprotein Cholesterol
ALP / Alkaline Phosphatase / INSUL / Insulin
ALT / Alanine Transaminase / K / Potassium
AMM / Ammonia / LAC / Lactate
AMS / Amylase / LDH / Lactate Dehydrogenase
AST / Aspartate Tramsaminase / LDL / Low Density Lipoprotein Cholesterol
BIC / Bicarbonate / MG / Magnesium
BIL / Total Bilirubin / NA / Sodium
CA / Calcium / PAR / Paracetamol
CARB / Carbamazepine / PBARB / Phenobarbitone
CHOL / Cholesterol / PHEN / Phenytoin
CK / Creatine Kinase / PO4 / Phosphate
CL / Chloride / SAL / Salicylate
CR / Creatinine / THEO / Theophylline
CRPR / C Reactive Protein / TP / Total Protein
DBIL / Direct Bilirubin / TRIG / Triglyceride
DIG / Digoxin / UA / Uric Acid
GGT / Gamma-glutamyl transferase / UR / Urea
Automated Immunoassays / Automated Urine Tests - Spot or 24hr Collections
B12 / Vitamin B12 / UAMS / Urine Amylase
BHCG / Serum bHCG / UCA / Urine Calcium
CKMB / CKMB Mass / UCL / Urine Chloride
COR / Cortisol / UCR / Urine Creatinine
FERR / Ferritin / UCR1 / Urine Creatinine
FOL / Folate / UGL / Urine Glucose
FSH / Follicle Stimulating Hormone / UK / Urine Potassium
FT3 / Free T3 / UMALB / Urine Microalbumin
FT4 / Free T4 / UMG / Urine Magnesium
LH / Luteinising Hormone / UNA / Urine Sodium
OESTR / Oestradiol / UPO4 / Urine Phosphate
PRL / Prolactin / UPR / Urine Protein
PROG / Progesterone / UUA / Urine Uric Acid
PTH / PTH (intact molecule) / UUR / Urine Urea
TESTO / Testosterone / Please contact the Laboratory Medicine Research Co-ordinator for details of test availability
HSTNT / High Sensitivity Troponin T
TSH / Thyroid Stimulating Hormone

Appendix 3 – Batch Analysis Worksheet – maximum numbers of samples in one batch is usually 100.