Sampling, storage and handling standards, consent procedures and templates

Task 4.1: Setting up standards, facilities and operating procedures for collection and storage of breast milk and blood/plasma samples (M1-M12) (UPPS, BBMRI, NVS, UCB, Pfizer) A protocol template will be developed that specifies minimum quality requirements for sampling of human breast milk, including maturity of breast milk (established milk supply vs immature milk or very mature milk); volume and timing of sample collection (e.g., relative to start of feeding event and dosing), how samples are to be stored, handled, and shipped up to delivery to the biobank. The standard template will consider measures to reduce patient burden and will be optimised with input from patients, clinicians and regulators, in collaboration with WP6 for stakeholder engagement. For each specific drug, a sampling protocol will be developed including sample type, time for drug administration, type of collection, tube, labelling, centrifugation, information management etc. Instructions for transportation of frozen samples will be set up. Protocols will be tested and implemented for one site/one study at the time in close collaboration with task 4.6. At Uppsala Biobank the samples will be received, checked and registered in the biobank LIMS and stored in low-temperature freezers. The biobank has already established facilities set up for freezers with proper alarm systems and back-up freezers and processes for managing any failures. A process for withdrawals of samples for the needs of the project for analysis at the analytical centre is available at Uppsala Biobank. The process will be adjusted to further suit the project needs and managing the biobank.