CPMS ‘How to’ Guide Recruitment Data Upload

Version 1.6

Appendix 5: How to upload Non­UK research activity Assumptions & Prerequisites Logging in Prefix: How to find a study you own

Using the main search box Using the filters

How to upload your data Step 1: Download the research activity already in CPMS, migrated from the NIHR CRN Portfolio for your study. (If this is a pre­existing open and recruiting study)

No recruitment to upload Step 2 : Download the Appropriate Template to populate. Step 3: Populating the templates and Accessing Site codes Step 4: Upload and validate your data to CPMS

Getting Help Appendix 1 : Recruitment Data Format and Definitions Appendix 2 How to obtain the correct Site Codes Appendix 3: Descriptions of each upload error and how to correct them Appendix 4: Adding a non NHS site into a study record Appendix 5: How to upload Non­UK research activity Appendix 6: Checking your new total recruitment figure

Document Change Control

Version Number

Date Revision Author Description

1.0 24/02/2016 CW Document creation

1.1 29/02/2106 CW Addition of Appendix 3 & 4

1.2 08/02/2016 DD Change Appendix 4 to step 1

1.3 14/02/2016 DD Addition of ‘Not passed Validation ­ Duplicate Data’ to Appendix 3

1.4 02/05/2016 DD Adding a 'non­nhs' site into a study record in CPMS Appendix 4

1.5 06/05/2106 SM Appendix 5: How to upload Non­UK research activity

1.6 27/05/2016 24/06/2016

DD Added a section for how to find a study you own. Prefix: How to find a study you own

Also added a link to the report no new research activity since last participant info ­ link to guide.

General updates and addition of Appendix 6: Checking your new total recruitment figure

1.7 29/06/16 14/07/16

DD & SM Removed appendix 4 it's covered in the locating the study you want and adding new sites. Guide Added a note appendix 2.5 How to filter for sites in the participating organisations tab.

Assumptions & Prerequisites Before you can upload recruitment data to a study, you will need a CPMS user

account with the Research Activity Coordinator, Study Co­ordinator, Chief investigator, Local Portfolio Manager (for the Lead LCRN) or National Portfolio Manager (for the Lead Administration) role.

All study team roles (within CPMS) are able to upload recruitment data however it is the Research Activity Coordinator who has overall responsibility for recruitment upload.

You have been set up as the Research Activity Coordinator (or any other study team role) for the study you will be uploading recruitment information for.

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The study status needs to have been updated to ‘Open’. (The National Portfolio Manager and the Study team can mark a Study as Open to Recruitment. To see or update the status of the study open the Study Record > Identifier and Status tab)

Logging in Here is the link to CPMS and a getting started with CPMS guide. When you log in, and you are directed to the CRN online learning platform, logout

and click the link to CPMS once again. 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. See screen shot below. If you do not have an NIHR account ­ Please see the Getting Started guide

Prefix: How to find a study you own 1. Once logged into CPMS, hover over the toolbar on the left ­ it will expand. Click on

the Studies tab to view a full list of studies in CPMS.

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

3. You can open any of the studies to view the study record by clicking the Study ID link or the Study short name link in the table.

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You can search by study ID, title or acronym, for example using the main search field. You can also use the filters ( you can use as many of the filters for one search as required) to search for a study or to return a group of studies, for example, you can filter studies by:

The study status (e.g open actively recruiting) The study speciality ­ you can click several specialties if the study has a dual

specialty or if you wish to return a list of studied from several specialties The Main RDO The Lead Admin. Lead LCRN The Study Route

Using the main search box The best way to search of a study if you know the study ID is to use the main search box. The main search box will search for anything related to that study, so if you type a study ID into the main search field, the returned list will pull up anything with that particular number anywhere in the study ID, IRAS ID, Study Title or Acronym. If you use a word from the study title or acronym instead, the search would have returned a list of all studies you have access to with that particular word present.

1. If you know just a section of the study short title or the Study ID number you can type into the SEARCH field. eg “5431” > Press SEARCH

2. The following will be returned: Any study with “5431” anywhere in the Study details.

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Using the filters If, for example if you want to return all studies that are Open and actively Recruiting, click on that option, it will then show as being ticked to indicate you have selected it.

1. You can then use the Specialty filter, you can select more than one filter in the list.

Again a tick box will indicate the chosen items.

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2. To complete your search click Apply filters.

3. The returned list can again be sorted using the arrows above each column in the

table. To open a study click on the Study ID or SHORTNAME link for that study.

The returned list here is showing all studies that are open and actively recruiting, that have Children, or Dementia or, Ear Nose and Throat as a specialty. The returned list will also include studies that any of the 3 selected specialties are supporting specialties not just managing specialty.

4. Your search is summarised at the top of the list

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5. You can press the Reset button to clear your search OR If you need to amend your

search to add or remove items from your search you can go back and click Show Filters and make the necessary changes.

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How to upload your data

Step 1: Download the research activity already in CPMS, migrated from the NIHR CRN Portfolio for your study. (If this is a pre­existing open and recruiting study)

Note: If this your first recruitment upload, see Step 2

1. Hover you mouse over the menu on the left to expand it > Click Studies

Warning: If you are running Internet Explorer 7 or 8, you will need to contact your local CRN representative for assistance in accessing your existing data, as you will not be able to view the Studies tab. The data provided will be in a format suitable for uploading into CPMS.

2. Locate the study you want to download information for using the sort columns or the filter functionality. See the prefix to this doc How to find a study you own

3. Once you have opened the study, go into Edit mode by clicking the Edit button

Warning: the information will not be visible unless you are in Edit mode.

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4. Go to the ‘Design’ tab

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5. Scroll down to the ‘Research Activities’ header > Click on the ‘Download Research

Activity for this study’ button.

6. The system will download a research activity template, populated with any research activity data already present in the system for your study.

You can then use this document as a template to add any further research activity into CPMS for future uploads.

Warning, any sites on your study record with no recruitment against them will be showing at the top of the downloaded spreadsheet, for your future use. If these lines do not have a valid Participant ID and so are not being used to record recruitment, they will need to be deleted before uploading, or they will cause a validation error.

No recruitment to upload To report no new research activity since last participant see the guide for what to do here Summary: Find the study in the Study view > Edit > Design Tab > Click Report No New Research Activity Since Last Participant

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Step 2 : Download the Appropriate Template to populate.

If this the first time you are uploading research activity data into CPMS you will need to download the correct template. If you are using Internet Explorer 7 or 8 CPMS will give you only a very basic version of the user interface. Non­Commercial studies are required to upload research activity using the Participant Level template.

If you have already downloaded the Template (or have received a pre­populated Template from another member of your study team) you can skip to: Step 2: Populating the spreadsheet and accessing site codes.

If research activity data has already been provided for your study, you can access this data from the study record, in the form of a pre­populated research activity file. See Step 1 for how to download the research activity already in the system for your study.

1. From the CPMS Home screen, hover your mouse over the toolbar on the left to expand it and click on the Research Activity tab

2. Download the appropriate Participant Level Template by selecting the correct version.

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Select the version appropriate for the version of Excel you are using (If you have a version of MS office between 97­2003, select the .xls file type. If you have a version of MS office 2007 and newer, please choose the .xlsx file type)

3. A new pop up box will open, choose a location on your machine to download and open the file.

4. The file will open in MS Excel ­ the spreadsheet contains all the column headings listed below (see Appendix 1 for directions on how to populate each column) :

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5. Populate the template with your recruitment information.

Please do not change, re­order, add or remove any of the column headings as you populate the spreadsheet.

Step 3: Populating the templates and Accessing Site codes See Appendix 1 (the Recruitment Data Format and Definitions Table) and Appendix 2 (How to find your site codes) for help in completing the Participant Level Template including how to find site codes. The Recruitment Data Format and Definitions Table provides a detailed list of the column names, and a description of the type and format of information required when populating each column of the Recruitment Data Template. You (the study team) will need to make sure that you add sites to the study record on the Participating Organisations tab before uploading data, as well as to your upload sheet. If sites are not added prior to upload a validation error will be displayed. CPMS checks that sites on the upload match the sites on your study record.

Please see the Locating the studie(s) you want and adding sites user guide for help adding sites to your Study record. Contact your Lead Local Clinical Research Network for help with adding sites if you need further assistance.

Step 4: Upload and validate your data to CPMS 1. Once you have populated the Template, make sure you Save it. 2. Back in CPMS, navigate back to the Research Activity tab.

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3. Click the Choose file button.

4. Locate the completed Recruitment spreadsheet on your machine's file system > Open

Once you have attached a file successfully you will see the file name next to the ‘choose file’ button

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5. Once you have chosen your file, click the Upload button

6. CPMS will now carry out some validation checks, and if there are any problems with your upload will display the first 10 validation errors

See Appendix 3 for a table of all the possible validation errors and how to correct them.

7. If your file passes the validation checks, you’ll be presented with a summary screen showing you how many participants had previously been recorded against your study, how many new participants were present in your upload, and the new total. (Note that the system will essentially ignore any lines of data where the participant ID is already present in the system).

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8. CPMS will also display several lines of data from your uploaded file to help you identify where any potential discrepancies may have occurred.

Please review this information carefully ­ do not submit if this total does not seem correct. Please re­check your spreadsheet prior to pressing submit as this can not be easily undone.

9. If the figures displayed are correct, in particular if the final number of participants recruited is accurate, you can proceed to commit this information into the system by scrolling to the bottom of the page and pressing SUBMIT

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OR

10. If you believe there is a problem with your recruitment data, and the numbers displayed are incorrect, please Cancel your upload, and contact your local CRN for support in troubleshooting any issues.

11. If you Submit, you’ll now receive a message that your recruitment information has been successfully uploaded.

To check your total participants recruited to date figure within the design tab of your study, to do this see Appendix 6

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Getting Help If you need any help with uploading recruitment data, please contact your local LCRN If you aren't sure who to contact, then please contact the Support My Study team at the NIHR CRN CC via supportmystudy@nihr.ac.uk

Appendix 1 : Recruitment Data Format and Definitions Participant Level Template

The table provides a detailed list of the column names, and a description of the type and format of information required in each column of the Recruitment Data Template.

Row Column Name

Format Description

A Study Identifier*

Numeric Unique identifier for a study (CPMS ID), previously known as the UKCRN ID E.g 43210

B Study Acronym*

Text Short name or acronym for the study.

This must be exactly as stated on the Study record.

C Site Identifier*

Alphanumeric A unique reference code allocated to a site. For most NHS sites this is an ODS code. This code can be located by clicking on the (i) button next to the site entry in the Participating Organisations tab of the study record. This must be exactly be as stated on the Participating Organisations Tab. See Appendix 2 for more detailed instructions.

C Site Name* Text Name of recruiting site This must be exactly be as stated on the Participating Organisations Tab.

E Activity Date*

Date Date of recruitment / screening activity Date of consent date for recruitment/screening activity

F Participant Type*

Category (select from a pre­determined list)

Type of participant. Valid options are : Carers; Diagnostic, screening or prevention participants; Genetically predispose; Other; Participant with the relevant condition; Participant without condition;

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Pre condition; Professionals; Relations. In the .xlsx version of the template spreadsheet this field is a dropdown.

G Unique Participant Id*

Alphanumeric Participant's Unique Study ID. Should not be an identifiable number. Must not be NHS number

H Activity Type*

Category (select from a pre­determined list)

CPMS will only accept the activity type ‘Recruitment’ for non­commercial studies. In the .xlsx version of the template spreadsheet this field is a dropdown. Click here for Recruitment FAQ’s and definitions

*This is a mandatory field.

Appendix 2 How to obtain the correct Site Codes Site code ­ this is a mandatory field. In order to obtain the correct site codes:

1. From the CPMS Home screen, hover over the menu on the left, it will expand, click the Studies tab.

2. Navigate to the study you are providing recruitment data for.

Please see the Locating the studie(s) you want User Guide for help filtering the Study list. ( Click Show Filters > use the search options to narrow down your search > click Apply Filters)

3. In the returned list of Studies, click on either the STUDYID or STUDY SHORTNAME link against the study you want to view.

4. In the Study view > Go to the Participating Organisations tab

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5. Under the Study Sites section of the page, there is a list of sites associated with your study displayed, click on the small info icon next to the site you need a site code for.

Note: To filter for sites in the participating organisations tab Click the column header, and the sort applies. You are also able to make additional columns visible using the 'Burger bar' icon to the top right hand side of the table. Finally, you can search for a site. The search function is currently case­sensitive, however if you use all­caps, this returns most NHS site names as this is how they are recorded in ODS, and thus in our reference data.

6. The corresponding site identifier / code will be displayed in the pop up box.

7. Copy and paste the site identifier into your recruitment spreadsheet. If keyboard shortcuts (Ctrl­C, Ctrl­V) do not work, select the Site ID, and use the mouse right click option to copy and paste the Site ID into your spreadsheet.

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Appendix 3: Descriptions of each upload error and how to correct them

Error How to correct.

Site Identifier not associated with this study

Check Identifier is correct as shown on >Participating Organisations Tab, and described in Appendix 2. If the site is not yet added to the study, please add it (using the ‘Add site’ button ­ if you require any support with this, please contact your lead LCRN or SupportMyStudy@nihr.ac.uk.

Study Identifier and Study Acronym do not match

Check that Identifier used is the CPMS ID (displayed in the top right hand corner of the study record) and the acronym matches the one displayed at the top of the study record. Be aware that when copying down using ‘Autofill’ in Excel the Study Identifier is automatically increased by 1 on each line, leading to a validation error on upload.

Participant Type is invalid Check type is one of the following options. Valid options are : Carers; Diagnostic, screening or prevention participants; Genetically predispose; Other; Participant with the relevant condition; Participant without condition; Precondition; Professionals; Relations.

Study (ID) is not yet open to recruitment

A National Portfolio Manager and the Study team can mark a Study as Open to Recruitment in the >Identifier and Status tab of the Study record..

The Study Status indicates that this study is not currently recruiting and therefore will not accept Research Activity.

A National Portfolio Manager and the Study team can update the study status to Open, Actively Recruiting in the >Identifier and Status tab of the Study record..

The research activity type provided is not currently valid for this study site. Please correct.

Only values of ‘Recruitment’ are allowed in this field.

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Click here for Recruitment FAQ’s

One of the Unique Participant ID's is an NHS Number. Please correct.

Check Participant ID’s ­ if you are using NHS numbers in this column, please update your participant ID’s so they do not use patient­identifiable information.

Study recruitment upload ‘required' is set to 'No' in the Study Design section of Study Record so Research Activity is not being accepted

Your study has been marked as not requiring research activity uploads. Please contact SupportMyStudy@nihr.ac.uk if you have any questions about this.

Your current role indicates that you do not have access rights to upload Research Activity for this study.

Only members of the study team, and certain NIHR network staff have access rights to upload for a study. If you are not a named role in the study team (as reflected in the study record in CPMS), please contact a member of the National Portfolio team in order to be granted the correct access.

ActivityDate or Activity Period is out of range. The date must fall between the study’s Actual Opening Date and today’s date.

A National Portfolio Manager and the Study team can change the study dates in the >Design tab of the Study record. Please note that changes to the actual opening date require approval (within the system) by the National Portfolio team.

The system cannot accept data from before 1st April 2006.

Please remove these row(s) from your file, and contact SupportMyStudy for guidance on how to proceed.

This upload contains dates outside the indicated period of the Study

The date must fall between the study’s Actual Opening Date and today’s date. Please check your dates if still correct. A National Portfolio Manager and the Study team can change the study dates in the >Design tab of the Study record. Please note that changes to the actual opening date require approval (within the system) by the National Portfolio team.

Not passed Validation ­ Duplicate Data CPMS will not accept the spreadsheet with no new participants as it has already retained this data. In order to notify CPMS of 0 additional participants. Please go to the Study Record > Edit > Notes tab > Add a note­­ “No recruitment since: (applicable date)” > mark the note category as ‘Recruitment note’ >Save. More info

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Appendix 4: Adding a non NHS site into a study record

1. Please use the 'Link Site' option on the Participating Organisations tab. 2. You should be able to find 'University of Manchester site for example ' ­ please

ensure you pick the one which has 'site' in the name as this is active. 3. Select No for non­NHS involvement and you should then be able to select the correct

LCRN where recruitment is taking place. See the Guide for Locating the study you want and adding sites for more information

Appendix 5: How to upload Non­UK research activity Overseas recruitment in CPMS is entered directly into the study record; individual site names do not need to be recorded and should not be included in the research activity upload template

1. Locate the study in the study record 2. Click the Edit button (this needs to be a study that you ‘own’) 3. Navigate to the Design tab ­ 'Non­UK Recruitment’ field 4. Enter the total number of overseas participants into this field in Edit mode 5. Press Save

No other information regarding these recruits is required

Appendix 6: Checking your new total recruitment figure You can check your recently uploaded figures within the design tab for the study record, under research activity. This will be a live figure.

1. From the menu bar on the left of the home screen > Click Studies. In view mode:

2. Click the Design tab.

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3. Scroll down the page to the pale blue sub­heading "Research Activities", you will see a section called "Current Activity",with the "Participants recruited to date" field.

In edit mode:

1. Click on the Design tab > scroll halfway down the page to the pale blue sub­heading "Research Activities" the second line down is the field "Participants recruited to date".

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