HTA TISSUE RECORD – ACCESS GUIDANCE This Access database has been designed to allow users to record and trace human tissue samples for a number of different projects; it will also allow one sample to be used for a number of projects without having to change the sample ID. The design of the database is such that you only need to input certain details once, these can then be used on subsequent forms. All of the forms are set so that only new records can be added, with the exception of the Change Consent Status and the Tissue Return forms. New data will automatically be saved when the form is exited, unless that record already exists. If a record with a particular unique ID is replicated Access will not save the entry, e.g. if tissue sample 1 has already been sent to recipient 3, Access will not permit a subsequent record of tissue sample 1 being sent to recipient 3 to be created. The database also contains a number of Queries and Reports. The HTA Annual Report will need to be produced annually for the HTA Co-ordinator in Governance and Compliance Division. The database can be modified to suit individual researchers needs, however, please note if the existing tables and relationships are altered this might affect the Annual Report. SWITCHBOARD FORMS When the database is opened, the switchboard will be displayed. This provides a shortcut to all the forms needed to record human tissue samples. Below is a description of the forms that are located on the Switchboard. Important: Both the Add New Sample and Tissue Location forms MUST be completed as soon as the tissue has been received. Add New Sample Once a new sample is obtained the Add New Sample form will need to be completed. This requires the sample ID, type of tissue and amount, who it was collected by and the collection date, it also requires information about consent – whether consent is in place, who it was taken by and where the consent form is located. If consent is obtained after the tissue has been added to the database, it is possible to update this information using the Change Consent Status form located on the Add New Sample form. Change Consent Status Occasionally surgical tissue may be taken and stored pending consent from the donor. This tissue must not be used for research until consent has been obtained, however it must be recorded on the database. The Change Consent Status form has been developed to allow researchers to record tissue and add the consent confirmation at a later date. Once the sample has been received the Add New Sample form must be completed, if consent is still pending the consent questions can be left blank. Once consent has been obtained, these details must be updated via the Change Consent Status form, which can be accessed through the Add New Sample form. To select the sample for which the consent status will be changed, place the cursor in the Sample ID box then search for the sample using the Search box in the menu bar at the bottom of the form. The search will display the first record that contains the numbers entered, if this is not the correct record press return until the correct record is displayed. Add New Recipient This form is used to add the details of the recipient and the project. More than one recipient can be added, and each one will be given a unique number that can be used in subsequent forms. This number is generated by Access and runs numerically. If a record is deleted the associated ID number will not be used for any subsequent records. If the tissue remains on site and it is known that the recipient will split the tissue, e.g. for different uses in one project or for different projects, each split must be entered into the database as a new recipient. Add New Storage Location This form will need to be completed for each location, both on- and off-site where the tissue is to be stored. Exact storage details may not be known for tissue sent off-site, in this instance simply select the ‘off-site’ option and exit the form. Please Note: All subsequent forms will ask for a combination of Sample ID and Recipient ID, this combination will produce a unique identifier permitting one sample to be sent to many recipients without affecting the original sample ID. It is essential for the functioning of the database that the combination of Sample ID and Recipient ID is unique. The Sample ID, Recipient ID and Location ID can be typed or looked-up, either type the correct ID number or click on the down arrow to select from the list. Tissue Location This is a very important form that links up the previous three forms. It must be completed every time a new sample is obtained or when a sample is split. This form links up the sample ID, the Recipient ID and the Location ID. Tissue Processing This form requires details of the tissue processing procedures. If tissue is sent off-site this must be recorded on the form as a ‘process’. Tissue Return If any tissue that has been sent offsite is returned at the end of the project, it must be recorded on this form. To select the sample that has been returned, place the cursor in the Sample ID box then search for the sample using the Search box in the menu bar at the bottom of the form. The search will display the first record that contains the numbers entered, if this is not the correct record press return until the correct record is displayed. Tissue Disposal This form requires details of the tissue disposal, including the reason for disposal, who carried out/authorised the disposal and disposal confirmation. There are several options for the ‘Reason for disposal’ that are available through a drop down menu. Human tissue should be incinerated; there is a tick box to confirm that the tissue has gone for incineration. If the tissue is disposed of in a way that does not involve incineration this must be documented under ‘other disposal method’. Note: It is important that the ‘disposal confirmation’ box is ticked when tissue has been disposed of, as this is used in compiling the Annual Report for Governance and Compliance Division. Documentation This report lists all the relevant documentation for compliance with the HTA licence. Local standard operating procedures can be displayed by adding them to the SOPs table (see below). TABLES, QUERIES AND REPORTS To access the tables, queries or reports click on the double arrow on the left hand navigation pane. Tables Data can be added directly into the table rather than using the form if preferred. The table below shows the forms that feed into each table. Form Add New Sample Change Consent Status Add New Recipient Add New Storage Location Tissue Location Tissue Processing Tissue Return Tissue Disposal Documentation Forms located on the Switchboard Table New Sample New Sample New Recipient Storage Location Use of Tissue Use of Tissue Use of Tissue Use of Tissue SOPs Switchboard Items Existing data can be imported directly to Access. Arrange the data into the column heading s of the Access Database and append it into the appropriate table in Access. Note: for the import to work, the column headings must have exactly the same characters as the headings in Access, though it is not case sensitive. To add additional documents to the SOPs table, simply insert the next numerical number into the ID column, add the title then double click on the paper clip to add the document. This will then be displayed in the report next time it is accessed. The files appear in the report in numerical order according to the ID number in the table, if you want to change the order in which the documents are displayed in the report, simply change the number in the ID column. Queries and Reports There are a number of queries and reports included in the database, most of which feed into the HTA Annual Report. Each query or report will provide information on the data contained in the database at that moment in time. Governance and Compliance Division require annual feedback regarding the number of tissue samples held for each project, running the HTA Annual Report will provide this information. The Human Tissue in Research Documentation report displays the information contained in the SOPs table. If additional documentation is added to the table, it will automatically appear in the report when accessed via the switchboard or directly from Reports. Additional queries and reports can be set up for individual researchers own needs.