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How to record capacity and capability

 

Contents

CPMS How to Guide

How to record Capacity and Capability data items against a Site within a Study Record

Assumptions & Prerequisites

➔ You will need a CPMS user account with the Local Portfolio Manager role.

➔ In CPMS, the Local Portfolio Manager will be able to provide information needed to assess whether each site has the capacity and capability to take part in a study. This will involve a joint conversation between study sponsor and the site.

Logging in

➔ See the CRNCC website for a link to CPMS (live) and a getting started with CPMS guide.

➔ For further materials log into CRN Learn with an IDG account to access the CPMS learning materials here.

➔ If you have an NIHR account you can login to CPMS using that by clicking the Log in with your NIHR account button.

➔ If you do not have an NIHR account ­ you will receive an e­mail when CPMS goes live and you will be able to reset your existing, pre-administered account password.

About the Capacity and Capability Step

This function captures site level data points related to assessing, arranging and confirming local capacity and capability to participate in the study as part of the HRA Approval process. These activities have replaced the granting of NHS permission at each site. The data points provide an overview of set­up times both individual sites and overall study..

Each site is responsible for undertaking these activities in conjunction with support from the Local CRN as required. In CPMS, the Local Portfolio Manager at the Lead CRN will be able to record whether each site has the capacity and capability to take part in a study. This will inform the CRN support required by the site and enable performance monitoring of the study.

CPMS will help provide reporting figures for this activity.

A local portfolio manager will be able to go into any study record where they are the lead CRN and provide the capacity and capability information that the Lead CRN has collected for the sites participating in that study. It is anticipated that the sites will collect this information as part of the LPMS minimum data set.

Step 1: Find the Study you want to action in CPMS

1. To find the study you want to action, hover over the toolbar on the left and Click on the Studies tab to view a full list of studies in CPMS.

Note: The study list is, by default,sorted in reverse order by ID. You can sort the study list by clicking on the small blue arrows at top of each column.

➔ You can also locate using a study by using the search options See the How to Guide for Finding a study in CPMS for help searching for and finding a study.

2. Once you have located and opened the study record ­ Click on the Design tab

3. Scroll down to view the Site list­. Here you can click on the small icon next to a site

➔ Here you will be able to view any Capacity and Capability information next to a site.

➔ You can hover over any of the small ‘information’ icons to give you more information about that field.

4. If this is a Study that is in your area you can edit the Capacity and Capability information Click the Edit button

5. Go back to the Study Design tab

6. Scroll down to the Site list

Note: If you are the Local Portfolio manager for this site, you would have the ability here to Edit the study and edit the data points for each site.

7. Click the small icon next to the site name you want to provide capacity and capability information for. A new window will pop up enabling you to enter the capacity and capability date information. This includes

➔ The Date Site Invited

➔ Date Site Selected

➔ Date Site confirmed

Or

➔ Non­ confirmation status

➔ Date site ready to start

8. Click on the data entry box for each data item you are asked to provide. A calendar date picker will pop up allowing you to easily select a date.

Note: The dates here need to be entered sequentially as each event would happen outside of the system. A red ‘No entry’ icon will appear over any previous dates on the date picker to the one entered in the text box above to indicate that any date entered here will need to fit the validation settings.

9. To change month or year, click the Month/Year at the top of the date picker , this will allow you to skip easily to a month from the current year.

10. To change the year click the year again at the top of the date picker to be able to easily choose another year without scrolling through.

Again hovering over any dates prior to any dates already entered will change your cursor to be a ‘blocked’ icon indicating you aren’t able to choose those dates.

It is possible to choose the same date as a previously entered date.

11. So here for example, the user has chosen the 9th of February 2016 for the Date Site Selected, we can see that any option to select a date prior to that for the Date Site Confirmed is blocked and you can only select either the 9th Feb or any later date.

12. For Date site Confirmed you can either enter a date for that field which denotes that the site will take part in that study OR enter a reason the site was not being confirmed as a study site via the Non ­ confirmation status field.

CPMS will not allow you to enter a data for both scenarios. So either indicate a date for the confirmation decision OR indicate a reason or status as to why a non confirmation decision has been made.

13. If the site has not confirmed capacity and capability to take part in the study you will need to indicate why by ticking one of the radio boxes: either the sponsor has declined site confirmation or the site has declined to participate.

Remember, if you have selected a reason why the site has not confirmed capacity and capability for the study, you will not be able to enter a Date Site ready to start date.

14. Once you have finished press OK.

15. Click the Save button on the study (top left hand corner of the screen). This is really important to make sure the data gets saved for reporting and others to see

 

Any information you have entered will now be accessible for anyone else looking at that particular site for this study.