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. 

• Prior to transport the partner site research team must ensure that the central co-ordinating site is aware that the samples are to be transported and are able to receive them upon arrival. 

• Frozen blood is transported on dry-ice by specialist courier service – contact central co-ordinating site for details and packaging instructions.
• Saliva samples are placed in Jiffy® bag, securely sealed and posted.
• Unfrozen blood, DNA, hair plucks and skin biopsies are securely sealed and posted.
• Frozen blood samples should always be shipped at the beginning of the week (Monday-Wednesday), to minimize the likelihood that samples are delayed over the week-end.
• Unfrozen blood, DNA, skin biopsies and hair pluck samples should be transported at the beginning of the week (Monday-Wednesday) whenever possible, to minimize the likelihood that samples are delayed over the week-end.

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.

• All samples collected at Guy’s and St. Thomas’ campuses and from partner sites are assigned a unique study number and the sample information entered onto the St. John’s Medical Dermatology database and into the laboratory sample log book with the following information
  • Unique study number
  • Patient’s name
  • Date of birth
  • Laboratory number – see below         
  • Date of sample
  • Disease and Protocol
  • Gender
  • Ethnicity
• All samples are assigned a laboratory number, generated sequentially from the laboratory sample book. This number is written on the sample tubes prior to storage and recorded on the accompanying clinical data sheet and entered onto the St. John’s Medical Dermatology database as above. 

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.

2.3.1 Storage

• Samples are stored in the appropriate manner prior to further analysis/extraction
  • Whole blood for DNA is to be stored at -20°C.
  • Saliva is to be stored at ambient temperature.
  • Whole blood for RNA, hair plucks and skin biopsies are to be processed immediately.
  • DNA is to be stored at -20°C.

2.3.2 Security

• All clinical data (including CRFs) and consent forms are to be securely stored separately in study specific site files in a locked office at the central co-ordinating site. Access to the central co-ordinating site is by swipe access.
• All electronic information regarding clinical data and samples will be stored on a password protected secure server.
• All samples are stored within a secure laboratory at the central co-ordinating site. Access to this laboratory is by swipe access, as is access to the central co-ordinating site itself.

Anonymised data will be kept on a password protected database.