LABORATORY MEDICINE CHECKLIST FOR APPROVING …



LABORATORY MEDICINE – RESEARCH REQUEST FORM

Please read guidance notes before completing this form.

|Section 1 |Core Information |

|Completed by Researcher | |

|STH Number | |

|Study Title | |

|(Abbreviated Title/Acronym) | |

|Recruitment Target at STH: |Funding (highlight): |Protocol Revision Number: |

| |Commercial or Non Commercial | |

|Amendments |Increase in work already agreed: |Y / N |

|Any STH amendment requiring additional work will | | |

|require Lab Directorate Approval via an RMS task. | | |

| |New tests required: |Y / N |

|Protocol Information: |Laboratory Tests |Schedule of Tests/Visits |

|State the pages in your protocol that summarise the | | |

|tests required and frequency of sampling. | | |

| | | |

|Sample Analysis: State which STH site the samples will|NGH, RHH or BOTH | |

|be sent to. | | |

|Human Tissue Act 2004 - “Where applicable, have HTA storage and disposal requirements been |Study Comment: |

|considered? (e.g. is the lab required to store samples containing cellular material beyond the | |

|standard duration required for routine testing?)” | |

|Section 2 |Laboratory Medicine Test Request |

|Completed by Researcher | |

| |Tests & Services Required |Standard Care |Research |Total Number of |Real Time or Batch |

|Only state the Tests and Services Required | |(per patient) |(per patient) |Research samples per test |Analysis |

|at STH Lab Med: | | | | |( R or B ) |

| | | | | | |

|1. Lists all the tests required at STH (see | | | | | |

|appendix 1&2 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 require Labs to analyse a Batch of | | | | | |

|samples that the study have previously | | | | | |

|stored frozen (if batch analysis is required| | | | | |

|state the maximum number of samples). | | | | | |

| | |

| | |

|Batch Analysis – for the Lab to take forward any such requests the study team will need to agree to our Batch Analysis |Yes / No / Not requested |

|Worksheet terms and conditions (see guidance p6 & appendix 3). | |

|HISTOPATHOLOGY - If YES, complete Section 3; if No, Researchers go to section 5 |Yes / No |

|Section 3 |Histopathology |

|Completed by Researcher | |

|(see guidance notes p6&7) | |

|1. Has a member of the histopathology team been contacted |Yes / No |If yes please give details of who has | |

|about this trial (Consultant or Biomedical Scientist)? | |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? | |

| | |

| | |

| | |

|6. Study Sponsor to State Agreement to Histology terms & |Name & Date of Confirmation: |

|conditions | |

|(see lab form guidance notes for section 3) | |

| |Organisation responsible for the return of blocks: |

|Section 4 |Laboratory Tests & Histology Costs |

|Completed by Lab Med: |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’. |

|STH - |Laboratory Test Methodology & Services may be subject to change and this is not an agreement to maintain the tests/services stated. |

|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 |Agreement to Lab Conditions |Y / N / Partial / NR |Fee if applicable | |

|Sample Handling | | | | |

|HISTOLOGY |The Histology tasks stated are indicative of what may be required, so please note that when the study is active all tasks |Research Cost Per Patient/Episode (£) |

| |requested will be charged for: | |

| | | |

|COMMENTS: | |

|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 |Research Approval & Information Required for Research Study Labels and the Reporting of Results |

|Completed by Researcher | |

|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: |Medic / Consultant |Address / Location (ward/room) |

| | | |

|For the reporting of results | | |

| | | |

|Clinical Query |Name |Telephone Ext / Bleep / Location |

| | | |

|State a contact for lab staff to use in | | |

|the event of an urgent clinical query | | |

| | | |

|Sample Query |Name |Telephone Ext / Location |

| | | |

|State a contact for lab staff to use in | | |

|the event of a sample query | | |

| | | |

|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: | |

|With the exception of WP, all ‘research’ samples should be sent to labs with a completed request form including the study |YES / NO |

|label provided by labs; and must not be ordered on ICE. Please state whether you want the ‘research’ test results to be | |

|available Electronically on ICE/Lorenzo/Portal? If ‘YES’ the results will be viewable to all users. Results can only go 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. | |

|Paper Hardcopy Result Reporting |YES / NO |

|Please highlight whether you require a paper hardcopy result report from Lab Med. | |

|Paperless - If you do not require a paper hardcopy report from Lab Med, you will need to access ICE. The CI/PI must confirm| |

|here or via email that the study team are aware of their own Directorate procedure for reviewing results, and that it is |CI/PI name and confirmation: |

|acceptable to the study sponsor that paper results are not issued by Lab Med. | |

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:

Laboratory Medicine Research Co-ordinator

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, - Cathryn.Leng@sth.nhs.uk 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

Researcher

First Contact – The core information and a clear identification of the type 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

Researcher

1. Only list the tests and/or services that are required at STH. State whether the test is regarded as Standard 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 (appendix 1) 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

Researcher

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

The Study should State their Acceptance of Histology terms for the release of tumour blocks from Sheffield Teaching Hospitals NHS FT Pathology Departments Diagnostic Archive, and 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

Researcher

For studies requiring the analysis of ‘research’ samples, arrangements must be made with the Lab Med RCO at least two weeks prior to the start of samples being sent to the laboratory. With the exception of WP, research samples must not be ordered on ICE. Research samples must be sent to Labs with a request form, containing a study label 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 |

|LDL |  |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 (pregnancy) |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.

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