To provide a standard operating procedure for the inter-site transport of human samples from partner sites and for processing of samples at the central co-ordinating site (i.e. Division of Genetics and Molecular Medicine, King’s College London (KCL), 9th Floor, Tower Wing, Guy’s Hospital, London SE1 9RT).
1. At partner sites
To maintain participant anonymity all samples shall be separated from their respective clinical data and transferred under separate cover. All sample tubes/containers shall be labelled with a site specific study number and date of sample collection. Samples collected at partner sites are transported to the central co-ordinating site.
Participant consent forms and psoriasis case report forms (CRFs) shall be labelled with the corresponding study number that relates to the subject in order for the clinical data to be matched to the sample at the central co-ordinating site.
A photocopy of all completed CRFs shall be transferred to the central co-ordinating site by post, or emailed. Original copies of the CRF shall be stored securely in the study site file at the partner site.
At partner sites' request, the central co-ordinating site will acknowledge to the partner site receipt of clinical data and samples within 24hrs via e-mail or telephone. Partner sites requesting acknowledgement of receipt shall include the request and contact details as a covering letter to be included with the shipment.
Participating sites will retain participant consent forms until the conclusion of the study, at which time the central co-ordinating site will make arrangements for the transfer of all study documents. Chief investigators at participating sites shall ensure that up-to-date consent is received from study participants and kept securely in the study file. The central co-ordinating site shall accept acknowledgement of consent on the patient CRF as confirmation that patient is consented to participate in the study.
2. Clinical Data and Sample Processing
Relates to samples and data received in the Division of Genetics and Molecular Medicine, KCL, Guy’s campus.
Once all clinical data, consents and samples have been collated, all clinical data and sample information must be entered onto the St. John’s Medical Dermatology database within 2 working days.
Anonymised data will be kept on a password protected database.
3. Long Term Storage
Any accompanying patient data will be removed from the samples to ensure patient anonymity. The samples will only be identified by the laboratory number assigned upon sample receipt.
DNA will be extracted from whole blood or saliva within 7 days from receipt of samples. DNA will be stored long term at -20°C at the central co-ordinating site.
RNA will be extracted from peripheral blood mononuclear cells immediately after receipt of samples. RNA will be kept at -80°C at the central co-ordinating site for long term storage.
Skin biopsy and hair plucks s will be processed immediately after receipt of samples. Immortalised cell lines may be established from skin /hair/blood samples and these will be stored in liquid nitrogen in the long term. Samples will be kept in a research bio-bank at St John's Institute of Dermatology, Guy's and St Thomas' NHS Trust (Ethics Approval Ref: 07/H0712/106; HTA License number 12521).
Whole exome sequencing data will be archived in the NIHR/BRC/GSTT/KCL computational cluster, which provides a secure, regularly backed-up platform for long term data storage.
Date: 23/10/14, Version 1