Efficient Clinical Sample Procurement with Partners

STANDARD-COMPLIANT SAMPLE PROCUREMENT WITH CLINICAL PARTNERS Peter M. Abuja This workshop has received funding from the European Union s Horizon 2020 research and innovation programmeunder grant agreement No 824110

Timeline of a study Ethical, legal considerations Concept Study design Ethics board Active study Study completed Clinical partner # of cases available Decide about Analysis and during study inclusion interpretation: Clinical workflow include clinicians Review clincal Integrate collection Case number and pathologists workflow into clinical Availability of workflow and Data storage, Develop material pathology publication and standardized Pathologist deployment sample collection Pathologist Suitability of process and secondary material documentation diagnosis selection of useable specimens support in aliquoting

Integrating the active study into the clinical workflow Study workflow Study documentation Include patient? Patient ID, data Sample collection transport processing storage analysis Patient admission Primary diagnosis Informed consent Medical treatment Pathology Phlebotomy Grossing Biopsy Selection of Clinical workflow material for Surgery Secondary diagnosis Study Medical documentation

Prepare your workflow to be done upfront Contact clinical partner and pathologist(s) Learn about clinical and pathology procedure Learn about suitable cases and frequency of occurrence Clinicians and pathologists have the last word regarding which samples you can get Sample collection must never interfere with treatment and diagnosis! Engage treating physician/clinician Must obtain IC and inform the patient Physician/clinician must understand the study to be able to explain it to the patient! Engage pathologist (for tissue samples) Can support you getting the right material, makes suggestions for proper dissection, etc.

Prepare your workflow steps to be performed to match clinical processes Keep order and keep it simple Pre-label everything Pre-order blood collection tubes in the right sequence Sequence must match sequence in documentation Avoid having changing personnel in the study, or train them all Instruct people involved in sample collection Train your partners in following standards and instructions Give reasons and explain consequences of non-compliance with standards

Prepare your workflow steps to be performed by you Keep order and keep it simple to avoid errors Prepare logically organized documentation (CEN/ISO) Pre-label everything For tissue aliquoting develop a simple, logical scheme Engage help if possible experienced Aliquoting and documentation should be separate tasks by different persons

Documentation Documentation templates according to CEN/ISO standards Modular templates for each part of the workflow Can be combined differently to give a project-specific documentation form Machine-readable paper forms best whenever documentation in different places, by different persons (form accompanies patient/ samples) No validity check during documentation No direct link to medical data Electronic form best for avoiding errors validity checking, direct linking of medical data, photodocumentation, etc. Difficult when moving between different departments/networks Difficult sometimes in a lab setting (gloves, decontamination) Largely a matter of (personal) preference

Documentation Documentation according to CEN/ISO standards Enrolment of patient Collection of specimen and transport Tissue aliquoting and storage Individual modules adapted for the study and merged

Documentation of enrolment of patient Is to be filled after patient signs informed consent Most data requested by standards may be documented before actual sample collection starts Complex data like diagnosis may be filed from electronic documentation, or depending on study, diagnosis may be pre-filled already in documentation (inclusion criterion) Data requested by standards Patient ID (coded), date of enrolment, diagnosis (free text copied from patient record, better: ICD-10 code), treatment (if needed by the study), sex, age (better age group, depending on study, sometimes year of birth) Confirmation that IC is available (remains usually in clinic), date of IC, name/ID of physician collecting IC Name/ID of person collecting these data

Collection and transport Filled in during/after surgery Documentation requested (described in use case): Repeat Patient ID, date of enrolment (check) Date and time of collection, specimen type, start of warm and cold ischemia, method of tissue extraction (surgery, biopsy document device used), Name/ID of person collecting tissue (this is not the surgeon!) Transport container and labelling must be pre-specified (brand, model, lot, ), any deviations noted Start of transport (date, time), transport conditions (e.g. 2-8 C, wet ice, temperature logged) Name/ID of person transporting the specimen Date & time of reception in laboratory, name/ID of person receiving, confirm check of patient ID, container label Specimen type and number of parts

Tissue work-up Described in the use case

Thank you Contact: Peter M. Abuja Medical University of Graz, Austria Peter.abuja@medunigraz.at