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How to complete a SoECAT

 

Contents

Applicants are advised to complete the AcoRD cost attribution training available here before completing the template and to not complete the SoECAT without support from their intended sponsor.

In completing a SoECAT researchers should follow the processes and policies of their intended sponsor organisation, i.e. some sponsors will have centralised support for completion of SoECATs, whilst others will have delegated their support within their organisation, e.g. to a research unit or other facility.

Researchers should not attempt to complete a SoECAT without sponsor support in line with the policies and processes of their sponsor.  Researchers should contact their sponsor in a timely manner to allow for the completion of SoECAT (and other support in making application for Research Cost funding).  Sponsors may not be able to support completion of a SoECAT (and hence AcoRD Specialist authorisation of the SoECAT may not be possible, which may mean that the Research Cost funding application cannot be made) if the researcher fails to engage with their intended sponsor early enough.

Sponsors may request support or advice from their local AcoRD Specialist in completing the SoECAT.  Although it is the role of the AcoRD Specialist to authorise completed SoECATs, not complete them on behalf of sponsors, sponsors may request support or advice where required.  Non-NHS Sponsors may also request support or advice from their lead NHS R&D Office.

The SoECAT is structured as a schedule of events and as such will appear familiar to many researchers.  A schedule of events lists the study activities to be undertaken at the site-level in the rows of the table and lists the study schedule (e.g. clinic visits, etc.) along the columns.  Traditionally the time points at which the activity is to be undertaken would be indicated by a cross or other mark in the relevant cell.  The SoECAT adopts this approach for the Standard of Care tab but replaces this mark with a drop-down menu that allows each activity in a General Activity or Per Participant tab to be attributed to an AcoRD cost category. If an activity will occur multiple times on the same visit (for example, hourly blood tests) the activity will need to be added on multiple rows. 

The Standard of Care, General Activities and Per Participant Activities Tabs (of which there are 5 in the standard SoECAT and 15 in the expanded version) are all formatted as schedules of events.

Prior to completing the schedule of events tabs, the Study Information tab should be completed, as per the guidance on the tab. The office use only section should be completed only by an authorised AcoRD Specialist and only after the template has been completed by the sponsor or their authorised delegate.  The schedule of events tabs will not work until question 3 on the Study Information tab has been completed.

Question five determines the number of tabs the summary pulls through, so it is important to ensure that this matches the number of tabs not necessarily the number of arms (assuming the study has arms).

The schedule of events tabs allow for standardised activities (investigations and procedures), with standardised costs, to be selected, as well as for activities not listed to be created, or for activities that do have standard costs listed to have study specific costs associated with them.

How to select activities

  • Check to see where the activity appears on the ‘List of Activities’ tab. (If it doesn’t appear, follow guidance on adding activities.)

 

  • Take note of the 'Area of Activity'

  • Go to the tab being completed, select the 'Area of Activity' from the drop-down-list - do this before selecting the 'Specific Activity' 

 

  • Select the 'Specific Activity' from the drop-down list


 

It is also possible to add procedures and/or investigations that are not present in the drop-downs, or to provide study specific costs for investigations already listed (e.g. where a more accurate cost than that provided in the tariff list is known for the study):

  • Go to the 'Non Tariff Costs' tab and enter the new activities. Also select relevant activity type (investigation or procedure)

  • If the new activity is an investigation, enter the associated costs

  • Return to the tab being completed and select 'Non Tariff Cost' from the 'Area of Activity' drop-down list. Do this before selecting the 'Specific Activity'.

 

  • Select the new 'Specific Activity' from the drop-down list.

Once you have selected a procedure on any tab, you should provide in the 'duration' column an estimate for the time that activity will take, in minutes. For investigations the duration column will be greyed out and should not be completed, (procedure costs are calculated on the basis of staff time, whereas investigations have fixed costs). You should then choose a staff-type from the drop- down menu in the 'undertaken by' column. This should be completed both for procedures and investigations.

Next you should indicate when each activity will occur. For the Standard of Care tab, you may either manually enter an 'x' or select 'x' from the drop-down menus. In the General Activity and Per Participant tabs, you should indicate that an activity is to occur by ascribing to it a cost attribution from the drop-down menu in the appropriate cell/s. An activity might occur once, or more than once, and should appear in each column where it is planned to occur. Cells in columns where the activity will not occur should be left blank. Cost attributions should be as per the AcoRD guidance:

Standard of Care tab

Once the Study Information tab has been completed as per the guidance, the Standard of Care tab should be completed (by selecting/adding activities as above).  In some instances it may be preferable to complete a Per Participant tab (see below) prior to, and as a guide to, completion of the Standard or Care tab (e.g. where a schedule of events has been drafted for the study activities and where this forms a useful starting point for differentiating the research from the standard care – see 47 for advice on copying and pasting between tabs).

If the study does not involve additional interventions to standard of care and also does not involve reducing the number or frequency of interventions (e.g. an observational study), this tab may be left blank.

In some interventional studies the participants to be recruited will have a clearly defined care pathway that they would follow if they were not in the study.  Where this is the case, and where the research care pathway/s differ from this standard of care, the standard of care pathway should be set out on this tab. 

In other studies, the standard of care pathway may be less clearly defined, less consistent between organisations/UK nations and/or there may in fact be multiple possible standards of care due to the study recruiting more than one type of participant.  Where this is the case, an ‘average’ or best approximation of the standard/s of care should be provided.

For the sake of accuracy and efficiency (e.g. where different tabs will contain significantly similar information) you may copy and paste between tabs by selecting the relevant columns and rows (columns A-AG only).  If copying from the Standard of Care tab into one or more of the Per Participant tabs you must replace the ‘x’s with the AcoRD cost attribution using the drop down boxes.  Where you are completing multiple Per Participant tabs with similar activities in each, you may also use the copy-paste function to provide a starting point before tailoring each tab appropriately.

General Activities Tab

Once the Standard of Care tab is completed the General Activities tab should be completed.

General activities are activities to be undertaken at a site-level that are not undertaken per-participant.  The General Activities tab divides these between ‘site set up’, ‘on trial’, ‘close site to recruitment’ and ‘site close out’.

Per Participants Tab/s

The Per Participant tabs are to be used to record activities that will be undertaken at site-level on a per participant basis (e.g. if there is one participant an activity may be undertaken twice, if two participants, the same activity would be undertaken four times, etc.)

Multiple Per Participant tabs are provided to allow for different pathways for different groups of participants, e.g. a study may have multiple arms, with each arm separately recorded on separate per-participant tabs.  It may also be appropriate to use more than one tab even if the study design does not formally involve multiple arms, e.g. a study that sees different participants within a single ‘arm’ may require different participants to undertake different activities dependent on a number of factors.  Whilst it may be difficult to estimate the number of participants who will follow which pathway at the time that the SoECAT is completed, best estimates may be made.

Where multiple Per Participant tabs are being completed it is good practice to name each, using “Study Arm, Phase or other Designator (optional)” at the top of each sheet, to help clearly differentiate and identify what each tab relates to.

Where a drug or device is provided free of charge you will need to use the turquoise box on the summary page to record this.