hta tissue record – access guidance

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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.
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