PERFORMANCE IN INITIATING AND DELIVERING CLINICAL RESEARCH CTP PLATFORM INSTRUCTIONS Version Control Entire Document Quick Tips Quick Tips, Item 27.a.xix and xxx Item 27.a.xxv Item 27.a.xvi Item 27.a.xxvi Reformatted for ease of use Added advice regarding downloading a new spreadsheet each quarter and not sharing spreadsheets between providers Added clarification regarding the process to ensure returns have been submitted successfully Added detail regarding what to do if an error is discovered after submission Added advice regarding how to prevent/resolve Data Mismatch errors Added advice regarding obtaining a copy of the returns for records/publication purposes before and after submission
For the financial year 2012-2013, NHS data for the Performance in Initiating and Delivering Clinical Research (PID) exercise was submitted using Excel spreadsheets uploaded to PID page of the NIHR Portal. A web-based submission system Clinical Trial Performance (CTP) Submission Platform has been developed for use from Quarter 1 2013-2014 onwards. From Q1 13-14, data can only be submitted through the CTP Submission Platform. CTP Submission Guidance will be issued as required and will include details of quarterly submissions and changes to the PID process. Contents Quick tips... 3 IT Requirements... 4 Account Creation and Management... 4 Managing Your Account... 8 Managing Submissions... 9 Using the Web Table... 12 Using the Spreadsheet Download... 13 Appendix 1: Validation... 23 CTP Submission Platform Instructions Sept 2015 v0.2 2
Quick tips The web-site for the CTP Submission Platform can be found at: https://ccfctp.nihr.ac.uk Please begin data entry and validation as soon as possible after each quarterly submission is opened. This will enable identification, reporting, and correction of any functional issues well in advance of the submission deadline. Spreadsheets are linked to specific providers and quarters. If you decide to work in the spreadsheet, be sure to download a new spreadsheet each quarter after deleting all old spreadsheets and never share spreadsheets between providers. Please add noreply@ccfctp.nihr.ac.uk to your safe sender email list in order to avoid communications from the platform being blocked by your local firewall. The login password you choose must be between 8 and 16 characters in length. This needs to contain at least one number, one upper case letter and one lower case letter, and one of the following symbols (shown in blue):! @ # $ % ^ & * ( ) _ + } { : ;. The submission window is a rolling 12 month period from the last day of the quarter. The data cut off is the last day of the quarter, not the submission deadline. Dates of submission windows for specific quarters can be found in sections 21 and 22 of the PID Guidelines 1. Any changes affecting data that occur between the end of the quarter and the submission deadline should be included on the following quarter s return. Clicking the Lock Table button in the web table will freeze the first (Title) row and the ID column to make entering data easier. This function will only work in Internet Explorer (IE) 9. Press Save to store your data on the system; please save regularly to avoid the potential loss of data. The system is set to time-out after 30 minutes and will not give you a warning. Spreadsheets should be opened and not saved when first downloading from the website but after macros are enabled, a local copy can be saved and shared internally if desired. Just be sure NOT to have the spreadsheet and the web form open at the same time. This could cause duplications and errors in your submission. The system will validate each record from left to right, and any errors will be explained in the Messages column on the far right of the table. The system may flag up errors if you save or validate before the record is complete; once you have completed the record correctly, hit Save, log off the system for a few minutes and when you log back in again, the validation should be resolved. Once you are happy with your data, you must click the Submit button in the web table in order to successfully submit your return. Clicking Upload in the spreadsheet will only pull through the data from the spreadsheet to the web table and does not submit your data. When you have successfully submitted, the page will refresh, a window will pop up acknowledging that you have successfully submitted, and you will no longer be able to edit the web table. You can confirm that you have successfully submitted by logging out of the system, logging back in again a few minutes later, and verifying that the RAG rating for the relevant quarter is a green circle and the status is showing as Accepted. Do feel free to contact the CTP team prior to the deadline at CTP@nihr.ac.uk if you would like us to verify that your returns have been successfully submitted. If you click submit and the page refreshes but your return is not submitting and no rows are highlighted with validation issues, scroll down to the very bottom of the page and check for an error message about repeated REC numbers under the web table. 1 http://www.nihr.ac.uk/documents/policy-and-standards/clinical-trial- Performance/Performance%20Guidelines%20Q1_1516%20FCTP.pdf CTP Submission Platform Instructions Sept 2015 v0.2 3
IT Requirements 1. The CTP Submission Platform is only compatible with the following computer systems: Operating Systems Microsoft Windows 7 and 8, Vista and XP. Please note that the Platform is not compatible with Apple/Mackintosh operating systems. Internet Browsers Internet Explorer 7 and above, Google Chrome 7 and above, Mozilla Firefox and above, Opera 10 and above. Microsoft Office Applications the CTP Submission Platform is only compatible with Microsoft Excel 2003, 2007 and 2010. The facility to enable macros is also an essential requirement. Account Creation and Management 2. The web-site for the CTP Submission Platform can be found at: https://ccfctp.nihr.ac.uk 3. To participate in the CTP Submission Platform, CCF will create an account for you based on your name, e-mail and the name of the organisation you represent. You will receive an automated e- mail asking you to validate your e-mail and provide you with a temporary password. 4. Only one account can be created per provider. If multiple people need to work on the submission, you can share your log in details or the spreadsheet can be downloaded and emailed to your colleagues. 5. If you do not receive an automatic email from noreply@ccfctp.nihr.ac.uk and the email is not in your spam/junk folder, please contact your local IT department to see if it has been blocked by the provider s firewall. If the IT department cannot find it, please contact the CTP team as soon as possible. 6. Once the automated email is received, follow the Account Verification Link to validate the email address provided. 7. Once the email address is verified, login to your account using the temporary password provided in the automated verification email. You can copy and paste this from the e-mail. CTP Submission Platform Instructions Sept 2015 v0.2 4
8. Once you have successfully verified your email, the system will notify you that your password has expired and ask you to change the password to one of your own choosing. 9. Click OK against the expiry message to bring up the Change Password function. CTP Submission Platform Instructions Sept 2015 v0.2 5
10. The password you choose must be between 8 and 16 characters in length. This needs to contain at least one number AND one upper case letter AND one lower case letter AND one of the following symbols (shown in blue):! @ # $ % ^ & * ( ) _ + } { : ;. Type or copy and paste the password given to you on the registration e-mail into the Existing Password field and then provide your New Password and confirmation of password and press OK. 11. Once you login you will be required to agree to these terms and conditions in order to proceed. CTP Submission Platform Instructions Sept 2015 v0.2 6
12. When you click OK, the system will open the CTP Submission Platform Home for your organisation. This will show any historical submissions from previous quarters as well as the most current open submission quarter at the top of the list. CTP Submission Platform Instructions Sept 2015 v0.2 7
Managing Your Account 13. Under the Your Account menu headings on the left hand side of the application, you will see a Personal Details option and a Change Email Address option. Please check your personal details when you first sign in to verify that they are correct. 14. To view or update your personal details, click the link under Your Account. Here you can update your title, name, job title and contact telephone number. Please note that you cannot update your organisation details; these are entered on your behalf by CCF. Also note that the organisation data on this system is provided by the Health and Social Care Information Centre, Organisation Data Service. If there is no value against the NHS Provider or it is incorrect, please contact CCF to get these details updated. 15. After you have amended your details, please press enter or Update to update your details and then click OK to the confirmation message. To cancel you need to select the cancel button on the screen. 16. Change Password a. To change your password at any time, please select the change password link. Please note that you need to choose a password which you haven t used on the system before. The new password must also be between 8 and 16 characters in length and should contain at least one number, one upper case letter and one lower case letter, and one of the following symbols:! @ # $ % ^ & * ( ) _ + } { : ; CTP Submission Platform Instructions Sept 2015 v0.2 8
17. Change Email Address a. To change your e-mail address, select the Change Email Address link. To change your e- mail you will need your existing e-mail address (the original one that you used to login), your current password and then you ll need to enter your new email address twice. Managing Submissions 18. Once your account has been set up and you have accessed the system and changed your password, you are ready to start making submissions via the CTP Submission Platform. 19. Select the Home Page link in the left hand menu under Your Account or Administration to return the submission home page at any time. This page will display the status of the submissions for the organisation you are representing. There are two submissions: one for Performance in Initiating and one for Performance in Delivering. CTP Submission Platform Instructions Sept 2015 v0.2 9
20. The Submission Dashboard a. For each organisation the CTP Submission Platform home page provides a dashboard for the current submission window for Performance in Initiating and Performance in Delivering data returns, further referred to as the submission type. Under each submission type is a table providing status information about the submission. b. RAG: A red, amber, green traffic light system is in operation to provide a visual cue regarding the progress of the submission. c. A green light indicates that the submission is on track. An amber light indicates that the submission deadline date is approaching and a red light indicates that the submission deadline has passed and that the submission is overdue. d. Name: This field indicates the name of the submission period, comprised of the quarter and year. e. Status: This is the status of the submission. Not Started means that the submission has not been opened for completion. In progress means that it has been opened or that the user has started to enter data but has not yet submitted the return. Accepted means that the submission has been validated and submitted to the system. f. Submission opens: This is the date that the submission window opens, when the return can be started. G. Submission deadline: Is the date by which the return must be submitted. NB: the data cut off is the last day of the quarter, not the submission deadline. Any changes affecting data that occur between the end of the quarter and the submission deadline should not be reflected on the return. 21. Data Completion Options a. To complete a submission you have two options: i. Enter the information into the web table. ii. Download a spreadsheet template, complete the details off-line, validate them, and then upload the data to the system via the spreadsheet. b. When a return has been successfully submitted, the status changes to Accepted. c. Both the web table and the spreadsheet validate the data entered to prevent errors and ensure high quality data. You cannot upload invalid data via the spreadsheet. There are two types of validation reports: CTP Submission Platform Instructions Sept 2015 v0.2 10
i. Fields that are mandatory and have not been completed according to the data submission rules are flagged with a red warning to notify the user. You must correct these in order to upload the spreadsheet and/or submit your data; and, ii. Fields that contain potential errors or are missing data are flagged with an amber recommended validation to notify the user (for example, when Valid Research Application, NHS permissions and/or First Patient Recruitment dates are not in chronological order). Data can still be submitted at the user s discretion; the system will not block submissions containing records with recommended validation. d. To start or open a submission click the View Submission link against the relevant return Performance in Initiating or Performance in Delivering. This will open the submission page. If you haven t already started your submission, you ll need to click Start to create the first row in your submission. This will set your submission status to In Progress. e. The Submission Details table provides information about the status of the submission, the date the submission window opened and the deadline for submission. It includes the submission type (i.e., Performance in Initiating or Performance in Delivering) and the name of the organisation making the submission. If this is wrong, please log out of the system and notify CCF immediately. The details table will also update to reflect the date that the submission is made. f. Click Start to generate your submission as shown below. You can then choose to complete the web table by selecting Add New Rows to the table, or you can click the button to Download Spreadsheet. CTP Submission Platform Instructions Sept 2015 v0.2 11
g. The system will automatically assign a line ID when a row is created and saved to the database do not worry if the IDs appear out of sequence. This is because multiple users may be creating and saving rows at any one time. h. Please use the scroll bar at the bottom of the page to view the complete contents of the screen. The < Back key will return you to the submission home page. i. NB: By Locking the web table, the first (Title) row and the ID column will be locked whilst you scroll down and to the right to improve ease of data entry. This function will only work in Internet Explorer (IE) 9. Using the Web Table 22. If you are using the web table to enter data, you will need to use the scroll bar at the bottom of the screen to navigate to the fields on the right. Alternatively, click in one of the cells of the row and use the tab key to navigate through the cells. Press SHIFT + TAB to move left (backwards) through a row. 23. Press Save to store your data on the system; please save regularly to avoid the potential loss of data. The system is set to time-out after 30 minutes and will not give you a warning. 24. Keep all comments to 500 characters or less. Even if you are able to enter more than that, the system will cut the comment after 500 characters. 25. The Name of Trial field currently only allows for 2000 characters. If the trial name is longer than that, please just enter the first 2000 characters and double check that the REC Number is correct. 26. The system will highlight any fields containing data that appears to be incorrect. Red highlighting indicates that it is mandatory to fix the error before the system will let you submit, and amber highlighting indicates that it is recommended that the issue is reviewed but the system will still let you submit. 27. Users can refer to the Performance in Initiating and Delivering Clinical Research Submission Guidance and FAQs for more information regarding how to complete the individual fields. Up to date versions of these documents can be found on the Performance in Initiating and Delivering Clinical Research website at: https://portal.nihr.ac.uk/sites/faculty/pid/pages/default.aspx. CTP Submission Platform Instructions Sept 2015 v0.2 12
Using the Spreadsheet Download a. Prior to opening and downloading the CTP spreadsheet from the CTP Submission Platform, the following checks must be made externally, regarding local permission in Microsoft Windows Excel. i. Open up your Excel application and under File choose Options and select Trust Center (options may vary depending on your version of Excel). ii. When the options window opens (shown below), go to the Trust Center menu on the left and then select the Trust Center Settings button in the right window: CTP Submission Platform Instructions Sept 2015 v0.2 13
iii. When the Trust Center Settings window opens, select Protected View in the left hand menu and edit the permissions settings. iv. NB: It is not necessary to disable all security settings in the Trust Centre, for example those regarding the opening of Outlook attachments, while using the CTP Submission Platform. Ensure that the settings are appropriate for use as disabling security measures may present a security risk from other applications. CTP Submission Platform Instructions Sept 2015 v0.2 14
v. Click the Download Spreadsheet button beneath the web table to download a spreadsheet. vi. If you are using Internet Explorer, be careful to choose the Open button to download the spreadsheet. vii. Do not press Save or Save As before opening the web table. Saving the downloaded spreadsheet locally will disable the uploading function of the downloaded spreadsheet. viii. Spreadsheets should be opened and not saved when first downloading from the website but after macros are enabled, a local copy can be saved and shared if CTP Submission Platform Instructions Sept 2015 v0.2 15
desired. Just be sure NOT to have the spreadsheet and the web form open at the same time! This could cause duplications and errors in your submission. ix. If you are working using Internet Explorer and have protected view settings in place, you may need to press Enable Editing and then Enable Content in order to access the spreadsheet. CTP Submission Platform Instructions Sept 2015 v0.2 16
x. If you are using Google Chrome, you should receive a security warning that reads, Macros have been disabled. Click the Options button. xi. This will bring up a Security Alert pop up. Click the Enable this content radio button and click OK. CTP Submission Platform Instructions Sept 2015 v0.2 17
xii. This will then display the authentication page. You will need to enter the e-mail address and password you normally use to access the CTP Submission Platform. If they do not match, you will receive an error message preventing you from accessing the form. CTP Submission Platform Instructions Sept 2015 v0.2 18
xiii. The system will then display a screen to say Contacting Validation Platform before opening the spreadsheet. xiv. Once the download is complete, you should save a local copy. The spreadsheet can be downloaded onto more than one machine and once downloaded according to these instructions, the spreadsheet will communicate with the submission platform, even when the internet browser is closed. xv. If you are copying and pasting into the spreadsheet, please use the command Paste as and then choose values. xvi. A Data Mismatch Error may occur if you paste data from another source (e.g., EDGE) and inadvertently copy and paste spaces, hidden characters or metadata. This can be avoided by pasting the data as values from the original source into a blank Excel spreadsheet and running TRIM and CLEAN functions on the data before copying and pasting the clean data into the CTP spreadsheet. xvii. Please note it is not possible to paste entire rows in to the spreadsheet download as the Duration and Benchmark Met fields complete automatically from information in the date fields. These fields will only auto-complete after you have completed the entire record and have hit Validate. xviii. The web table and the spreadsheet must not be open at the same time and the data must be validated by clicking the Validate button at the top of the spreadsheet before the data can be uploaded to the platform. xix. The spreadsheet can otherwise be completed very much like the web table. Once you have validated the data and corrected any errors, upload the data from the spreadsheet into the web table by pressing the Upload Submission button. NB: this only uploads your data onto the website; you still need to go into the website and press the Submit button to successfully submit your return. xx. The ID, Benchmark Met and three Duration columns are all automatically populated by the system using the data you provide, so please do not attempt to complete them. Most of these columns are read-only, but if you are able to enter any data into them, it will be deleted when you upload the spreadsheet. xxi. Note that whilst the labels for some of the possible reasons for not meeting the benchmark have changed, the definitions have not. xxii. NB: If the Benchmark Met is No, it is mandatory to select at least one reason for delay (i.e., A-J) and a source of delay (i.e., NHS Provider/Sponsor/Neither/Both). xxiii. If you wish to close a session but continue uploading at a later time, upload the data that is already entered and re-open later. The data uploaded and saved within the CTP Platform itself will be available in the spreadsheet when downloaded in a later session. CTP Submission Platform Instructions Sept 2015 v0.2 19
xxiv. The system will take you through the authentication process again, but you will not receive a confirmation that your data has uploaded. However, you should now be able to see the data you have entered in the spreadsheet in the web table when you go back to the Submission home page. Again, be sure to save and close the spreadsheet before opening the web table to check if your data has uploaded successfully. xxv. If you notice an error after you have clicked Submit, please contact the CTP team as soon as possible. We will be able to reopen your return for you to correct the error as long as you contact us prior to the deadline, but not after the CTP Submission Platform Instructions Sept 2015 v0.2 20
deadline has passed. However, reopening returns will cause delays for you and for the CTP team, so please log out for a short while and log back in again before double checking your data is correct and all validation issues have been resolved before clicking the Submit button. xxvi. If you would like to download a copy of your finalised spreadsheet to keep for your records or to use for publication on your provider s website, you must do this before hitting Submit. If you have already clicked Submit and the deadline has passed, you should still be able to highlight the data in your completed return and paste it into a blank Excel spreadsheet or Word document. xxvii. Once you are happy with your data, click the Submit button. xxviii. The page should refresh and you should no longer be able to edit the web table. CTP Submission Platform Instructions Sept 2015 v0.2 21
xxix. If you are notified that the CTP Platform is being fixed, please make sure to shut down all current sessions, preferably by opening the Task Manager and ending any Excel applications and processes, since these can run in the background and through the browser cache and will interfere with fixes. xxx. Once you have submitted, the RAG will turn to green and the status will become Accepted. Please log out again and log back in to verify that this has occurred. If not, then your submission is not complete and you should contact the CTP team immediately. CTP Submission Platform Instructions Sept 2015 v0.2 22
Appendix 1: Validation 1. In order to ensure high quality data, several validation measures have been put in place as briefly mentioned under Submission Options above. Red alerts will prevent you from uploading your submission and amber alerts will flag questionable records but will still allow you to submit. ERROR MESSAGES AND VALIDATION FOR PI Data Field Data Format Error Message Research Ethics Committee Reference Number Alpha-numeric characters, including symbols ( / ) If field is blank Please enter a valid REC number Name of Trial Alpha-numeric characters (2000characters) If field is blank Please enter the Name of Trial (up to 250 characters) Date of Receipt of Valid Research Application In the format dd/mm/yyyy 1.If field is blank 2.If date is in wrong format 1.Please indicate Date of Receipt of VRA 2.Please enter Date of Receipt of VRA in the format dd/mm/yyyy Date of NHS Permission In the format dd/mm/yyyy 1.If field is blank 2.If date is outside of range 3.If date precedes Date of Valid Research Application 4.If date is in wrong format 1.Please indicate Date of NHS Permission 2.Date of NHS Permission is outside submission window 3.Date of NHS Permission predates Date of Valid Research Application 4.Please enter Date of NHS Permission in the format dd/mm/yyyy First Patient Recruited? Drop down; Yes/Yes Date Unavailable/No 1.If no option is selected 2.If different terminology is used 1.Please indicate if the first patient was recruited 2.Please only select options from the drop-down CTP Submission Platform Instructions Sept 2015 v0.2 23
Data Field Data Format Error Message Date of First Patient Recruited In the format dd/mm/yyyy 1. If field is blank when First Patient Recruited? Is Yes 2. If date is entered when First Patient Recruited? Is Yes date unavailable or No 3.If date precedes Date of Valid Research Application or Date of NHS Permission 4.If date is entered in different format 1. and 2. If you have indicated that a patient has been recruited, please enter a recruitment date. If a patient has not been recruited or date is not available, please leave blank. 3.Date of First Patient Recruited predates Date of NHS Permission or Date of Valid Research Application 4.Please enter date in dd/mm/yyyy format A Permissions delayed/denied Drop Down; A-J Yes/Blank 1.Field completed with other terminology 1.A-Permissions delayed/denied: please ensure you select from drop-down menu B Suspended by sponsor Drop Down; A-J Yes/Blank 1.Field completed with other terminology B Suspended by sponsor: please ensure you select from drop-down menu C Closed by sponsor Drop Down; A-J Yes/Blank 1.Field completed with other terminology C Closed by sponsor: please ensure you select from dropdown menu D Sponsor delays Drop Down; A-J Yes/Blank 1.Field completed with other terminology D Sponsor delays: please ensure you select from dropdown menu E Staff availability issues Drop Down; A-J Yes/Blank 1.Field completed with other terminology E Staff availability issues: please ensure you select from drop-down menu F No patients seen Drop Down; A-J Yes/Blank 1.Field completed with other terminology F No patients seen: please ensure you select from dropdown menu CTP Submission Platform Instructions Sept 2015 v0.2 24
Data Field Data Format Error Message G No patients consented Drop Down; A-J Yes/Blank 1.Field completed with other terminology G No patients consented: please ensure you select from drop-down menu H Contracting delays Drop Down; A-J Yes/Blank 1.Field completed with other terminology H Contracting delays: please ensure you select from dropdown menu I Rare diseases Drop Down; A-J Yes/Blank 1.Field completed with other terminology I Rare diseases: please ensure you select from dropdown menu J Other Drop Down; A-J Yes/Blank 1.Field completed with other terminology J Other: please ensure you select from drop-down menu Comments Free-text 500 character limit 1.Field completed with other terminology Word limit exceeded Reasons for delay correspond to: Drop Down; NHS provider/sponsor/both/neit her 1.Field completed with other terminology 1.Reasons for delay correspond to: please select from the drop down options ERROR MESSAGES AND VALIDATION FOR PD Data Field Data Requirement Possible Error Validation Research Ethics Committee Reference Number Alpha-numeric characters, including symbols ( / ) 1.If field is blank 1.Please enter a valid REC number Name of Trial Alpha-numeric characters (2000 characters) 1.If field is blank 1.Please enter the Name of Trial (up to 250 characters) CTP Submission Platform Instructions Sept 2015 v0.2 25
Data Field Data Requirement Possible Error Validation Target number of patients available Target number of Patients Date Agreed to recruit target number of patients available Drop Down; Available/No target agreed with sponsor Numeric up to 5 digits Drop Down Agreed/No date agreed with sponsor 1.Field left blank 2.Field with other terminology 1.Field left blank when target number of patients available is Available 2. Field completed when target number of patients available says no target agreed with sponsor. 3.Range entered or other format 1.Field left blank 2.Field with other terminology 1.Please indicate if Target number of patients is available 2.Target number of patients available: please choose from the drop-down fields 1.Please indicate the target number of patients 2.Please remove target number of patients or review the Target number of patients available field 3.Target number of patients should be entered as a number 1.Please indicate if Date Agreed to recruit target number of patients is available 2.Date agreed to recruit target number of patients: please choose from the drop-down fields Date Agreed to recruit target number of patients In the format dd/mm/yyyy 1.Field left blank when date agreed to recruit target number of patients available is Available 2. Field completed when date agreed to recruit target number of patients available says no date agreed with sponsor. 3.Range or other format entered 1.Please indicate the date agreed to recruit target number of patients 2.Please remove date agreed to recruit target number of patients or review the Date Agreed to recruit target number of patients available field 3.Date agreed to recruit target number of patients should have the format dd/mm/yyyy Trial status Drop Down; In setup/open/closed in follow up/closed follow up complete/suspended/withdrawn 1.Field left blank 2.Field with other terminology 1.Please indicate Trial status 2.Trial status: please select from the drop-down options CTP Submission Platform Instructions Sept 2015 v0.2 26
Data Field Data Requirement Possible Error Validation Target met within the agreed time Drop Down 1.Field left blank 2.Field with other terminology 1.Please indicate if the target was met within the agreed time 2.Target met within the agreed time: please select from the drop-down options Comments Currently free-text 500 character limit 1.Only exceeding character limit 1.Word limit exceeded CTP Submission Platform Instructions Sept 2015 v0.2 27