![]() Kits can be selected using the checkboxes to the left of the list, or by clicking anywhere on a row. (1-3 7-8) or (1-3,7-8) - rows with value within the range of 1 to 3 or 7 to 8.1-3 - rows with value within the range of 1 to 3.(1 2) or (1,2) - rows with value 1 or 2.Numeric columns (displayed with a lighter font colour and aligned to the right) behave slightly differently: (A B) C or (A,B) C - rows matching A or B and C.Text or date columns can be filtered using statements like: The list can be filtered and sorted using the controls in the table headings. Does not include changes made by the user on the code list page Timestamp of last update to kit made by the system (such as dispensing). Period before the expiry date during which the kit must not be allocatedĬurrent status of the kit: Unmade, New, Dispensed, Quarantined, Lost, Damaged, or DestroyedĬurrent location of the kit: Manufacturer, Distributor, Site, or Other Optional record of manufacturer's lot or batch numberĭate after which the kit must not be used Type of kit – will be 'Standard' by default but a trial may be configured to allow variants such as kit size or dosage The unique code used to identify a specific kit The columns shown in the code list are: Sequence It will not be shown for trials that are not shipping kits to sites, such as trials where the drug is made up in the pharmacy on demand using bulk supplies.Įxpired kits and those without an expiry date are greyed out. Viewing a code listįor trials that have a code list, a Code list link may be shown in the top menu to administrators. This is to prevent kits being dispensed that may expire during the period of their use. Kits will not be dispensed in the buffer days leading up to the expiry date either. Kits must be given an expiry date, and that date must be in the future before they can be dispensed (kits will not be dispensed on the date of expiry). Batchīatch is optional but is intended to record the manufacturer's lot or batch number. It has no other function - in particular do not assume that kits are given out in sequence number order (see dispensing policy below). The sequence number is used to order the code list in a consistent, reproducible manner. Randomisation kit code is the kit code given out at randomisation. Note, however, that the kit blocks in the code list are not related to the block sizes chosen to balance the randomisation if random permuted block randomisation is in use. For instance, a block of 4 in a trial with 1:1 ratio will contain 2 active and 2 placebo treatments. Kits are often shipped in whole blocks and the blocks are balanced to represent the randomisation ratio. Some trials may have different types of kits, such as different bottle sizes, different dosages or rescue medication.Ī kit block is an administratively convenient block of kits and is used in the dispensing policy (see below). The format of a kit code is usually numeric or alphanumeric (e.g. The kit code will be printed on the packaging and given out by the randomisation system. The kit code is a unique code assigned to a kit. Multiple kits may be given to the same participant, for instance at scheduled follow-up visits or because the original kit has been lost or damaged. In practice a kit may be a vial, a bottle containing pills, a pack containing multiple vials etc. KitĪ kit is a unit of the investigational product or placebo that will be given to a single participant. TerminologyĪ consistent terminology is used throughout the randomisation system, although in practice different trials may use alternative terms. The randomisation system does not display the treatment group, but it is useful for administrators to view the other columns in the code list because it shows the location of trial treatments and whether they are available for use. Here is an example of a code list in the randomisation system It is used by the drug packager or pharmacist, for instance, to label the active and placebo treatments with the kit code - see the FAQ for more information. The code list provides the confidential link between the kit codes and the true treatment group. Code lists (also known as kit or medication lists) are only relevant to double blind trials.
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