CTP SUBMISSION PLATFORM

Transcription

1 CTP SUBMISSION PLATFORM INSTRUCTION DOCUMENT Version Control Two notes of clarification added regarding data cut off and completion requirements The Submission Dashboard, p 10 Using the Spreadsheet Download, p 18 Note added highlighting the dates for data cut off as compared to the submission deadline Note added highlighting that the selection of at least one reason and a source of delay is mandatory if Benchmark Met is No CONTENTS Introduction... 2 Account Creation and Management... 3 Managing Your Account... 7 Change Password... 7 Change Address... 8 Managing Submissions... 8 The Submission Dashboard... 9 Data Completion Options Using the Web Table Using the Spreadsheet Download Appendix 1: Validation and Troubleshooting Validation Error Messages and Validation for PI Error Messages and Validation for PD Version 4.0-Mar CTP Submission Platform Instructions 1 of 27

2 INTRODUCTION For the financial year , NHS data for the Performance in Initiation and Delivery of clinical research was submitted using Excel spreadsheets uploaded to the Performance in Initiating and Delivering Clinical Research page of the NIHR Portal. A new web-based submission system Clinical Trial Performance (CTP) Submission Platform has been developed for use from Quarter onwards. From Q , data should 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 Performance in Initiating and Delivering Clinical Research process. IT Requirements 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 The facility to enable macros is also an essential requirement. IMPORTANT NOTE: It is requested that Research and Development staff responsible for the entry, validation and submission 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 data submission deadline. Version 4.0-Mar CTP Submission Platform Instructions 2 of 27

3 ACCOUNT CREATION AND MANAGEMENT The web-site for the CTP Submission Platform can be found at: To participate in the CTP Submission Platform, CCF will create an account for you based on your name, and the name of the organisation you represent. You will receive an automated asking you to validate your and provide you with your one-time password. TROUBLESHOOTING TIP: 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 ed to your colleagues. If a designated user does not receive an automatic from noreply@ccfctp.nihr.ac.uk then this address should be added to the user s Safe Sender list by their local IT staff. Once the automated is received: -Follow the Account Verification Link to validate the address provided. -Once the address is verified, login to your account using the temporary provided in the automated verification . You can copy and paste this from the . TROUBLESHOOTING TIP: if you try to sign in to the system without verifying your e- mail address, you will receive an error message informing you of this. If you cannot find the , check that the hasn t gone to your junk folder and then click the Resend link. Version 4.0-Mar CTP Submission Platform Instructions 3 of 27

4 Once you have successfully verified your , the system will notify you that your password has expired and ask you to change the password to one of your own choosing. -Click OK against the expiry message to bring up the Change Password function. Version 4.0-Mar CTP Submission Platform Instructions 4 of 27

5 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 # $ % ^ & * ( ) _ + } { : ;. Type or copy and paste the password given to you on the registration into the Existing Password field and then provide your New Password and confirmation of password and press OK. Once you login you will be required to agree to these terms and conditions in order to proceed. Version 4.0-Mar CTP Submission Platform Instructions 5 of 27

6 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. Version 4.0-Mar CTP Submission Platform Instructions 6 of 27

7 MANAGING YOUR ACCOUNT Under the Your Account menu headings on the left hand side of the application, you will see a Personal Details option and a Change Address option. Please check your personal details when you first sign in to verify that they are correct. 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. 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. CHANGE PASSWORD 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. As when the password was changed upon initial login, the new password must be between 8 and 16 characters in length and should contain at least one number AND one upper case letter AND one lower case letter AND one of the following # $ % ^ & * ( ) _ + } { : ; Version 4.0-Mar CTP Submission Platform Instructions 7 of 27

8 CHANGE ADDRESS To change your address, select the change address link. To change your you will need your existing address (the old one that you used for sign-on), your current password and then you ll need to enter your new address twice. MANAGING SUBMISSIONS 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. Select the Home Page link in the left hand menu bar 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 available, one for Performance in Initiating and the other for Performance in Delivering. Version 4.0-Mar CTP Submission Platform Instructions 8 of 27

9 Visual RAG status indicator: Green On track, open for submission or submitted Amber deadline approaching Red - overdue Name of the submission period and submission type Status description: Not started = not opened yet In Progress = opened or in the process of completion Accepted = submitted Submission Window Open Date Submission Deadline Date Hyperlink to open and view or edit the submission THE SUBMISSION DASHBOARD For each organisation the CTP Submission Platform home page provides a dashboard for the current submission window for the data returns for Performance in Initiating and Performance in Delivering, otherwise described as the submission type. Under each submission type is a table providing status information about the submission. RAG: A red, amber, green traffic light system is in operation to provide a visual cue regarding the progress of the submission against the target. 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. Name: This field indicates the name of the submission period, comprised of the quarter and year. 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 submission details but has not finalised them and submitted to the system. Accepted means that the submission has been validated and submitted to the system. Submission opens: This is the date that the submission window opens, when information can first start to be entered. Submission deadline: Is the date by which the return must be submitted. NB: 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. Version 4.0-Mar CTP Submission Platform Instructions 9 of 27

10 DATA COMPLETION OPTIONS To complete a submission you have two options: 1. Enter the information into the web table. 2. Download a spreadsheet template, complete the details off-line, validate them, and then upload the data to the system via the spreadsheet. When details have been submitted the status is shown as accepted. Both the web-table and the spreadsheet download validate the data entered to ensure it complies with the data submission rules you have been provided with. You cannot upload invalid data via the spreadsheet. There are two types of validation reports: 1. 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 details; and, 2. Fields that are potentially erroneous or non-compliant with submission requirements are flagged with an amber recommended validation to notify the user (for example, Valid Research Application, NHS permissions and/or First Patient Recruitment dates not in chronological order). Data can still be submitted at the user s discretion, the system will not block submissions of records containing flagged items. 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. The Submission Details table provides details of the status of the submission, the date the submission window opened and the deadline for submission. It provides the type of the submission, i.e., Performance in Initiating or Performance in Delivering, and the name of the organisation making the submission. If this is wrong, please do not proceed and notify CCF. The details table will also contain the date that the submission is made. Version 4.0-Mar CTP Submission Platform Instructions 10 of 27

11 Click Start to generate your submission record as shown below. You can then choose to complete the web page by selecting Add New Rows to the table, or you can select the button to Download Spreadsheet. 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. Please use the scroll bar at the bottom of the page to scroll to see the complete contents of the screen. The <Back key will return you to the Submission home page. NOTE: By Locking the web table, the first (Title) row and the ID column will be locked to improve ease of data entry. This function will only work in Internet Explorer (IE) 9. Version 4.0-Mar CTP Submission Platform Instructions 11 of 27

12 USING THE WEB TABLE If you are using the web table to enter details, 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 to the right. Press SHIFT + TAB to move left (backwards) through the cells of a row. 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. TROUBLESHOOTING TIPS: 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. 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. The system will highlight any fields containing data that appears to be in error. A red highlight is mandatory information which must be corrected and comply with the submission rules, amber is a flag to check whether the data is valid but will not block submissions. 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: USING THE SPREADSHEET DOWNLOAD 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. 1. Open up your Excel application and under File choose Options and select Trust Center (options may vary depending on your version of Excel). Version 4.0-Mar CTP Submission Platform Instructions 12 of 27

13 2. 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 : 3. When the Trust Center Settings window opens, select Protected View in the left hand menu and edit the permissions settings. Version 4.0-Mar CTP Submission Platform Instructions 13 of 27

14 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. Click the Download Spreadsheet button beneath the web table to download a spreadsheet to your local machine. If you are using Internet Explorer, be careful to choose the Open button to download the spreadsheet. Version 4.0-Mar CTP Submission Platform Instructions 14 of 27

15 Do not press Save or Save As. Saving the downloaded spreadsheet locally will disable the uploading function of the downloaded spreadsheet. TROUBLESHOOTING TIP: 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 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. 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. Version 4.0-Mar CTP Submission Platform Instructions 15 of 27

16 If you are using Google Chrome, you should receive a Security Warning that reads, Macros have been disabled. Click the Options button. Version 4.0-Mar CTP Submission Platform Instructions 16 of 27

17 This will bring up a Security Alert pop up. Click the Enable this content radio button and click OK. This will then display the authentication page. You will need to enter the 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. Version 4.0-Mar CTP Submission Platform Instructions 17 of 27

18 The system will then display a screen to say Contacting Validation Platform before opening the spreadsheet. Once the download is complete, it is advised that a copy is saved locally. 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. TROUBLESHOOTING TIP: A Data Mismatch Error may occur when a user attempts to paste data in to the downloaded spreadsheet owing to erroneous characters surrounding the source data. For example if original trials data is sourced from another data management platform such as EDGE, the sourced data may present additional unwanted characters when pasted in to CTP Spreadsheet. The web table and the spreadsheet must not be held open at the same time and prior to uploading data to the submission platform; the data in the spreadsheet must be validated, using the Validate button at the top of the spreadsheet. The spreadsheet can otherwise be completed very much like the web table. To upload the data entered to the spreadsheet after validation, press the Upload Submission button. TROUBLESHOOTING TIPS: 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. If you are copying and pasting into the spreadsheet, please use the command Paste as and then choose values. Note that whilst the labels for some of the possible reasons for not meeting the benchmark have changed, the definitions have not. 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 ( autocomplete ). These auto-complete fields will only complete after the remained of the data in a record is complete and the Validate button is selected. 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). TROUBLESHOOTING TIP: 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. Version 4.0-Mar CTP Submission Platform Instructions 18 of 27

19 TROUBLESHOOTING TIP: CCF advises that entire submissions are made as close to the deadline to accommodate omitted data points and prevent the need for submissions to be re-opened. 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. Once you are happy with your data, click the Submit button. Version 4.0-Mar CTP Submission Platform Instructions 19 of 27

20 The page should refresh and you should no longer be able to edit the web table. Version 4.0-Mar CTP Submission Platform Instructions 20 of 27

21 TROUBLESHOOTING TIP: When notified that the CTP Platform is being fixed, users should make sure they 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. Once you have submitted, the RAG will turn to green and the status will become Accepted. A FEW MORE TROUBLESHOOTING TIPS: When notified that the CTP Platform is being fixed, users should make sure they 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. Providers should wait until the submission deadline to actually submit their returns (because otherwise we have to reopen them). If Providers want to download their completed spreadsheet for their records, they have to do it before they submit their return. Version 4.0-Mar CTP Submission Platform Instructions 21 of 27

22 APPENDIX 1: VALIDATION AND TROUBLESHOOTING VALIDATION 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 (see 2 in previous column) 1.Please indicate Date of NHS Permission 2.Date of NHS Permission is outside submission window 3.If date precedes Date of Valid Research Application 3.Date of NHS Permission predates Date of Valid Research Application 4.If date is in wrong format 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 they don t select an option 1.Please indicate if the first patient was recruited Version 4.0-Mar CTP Submission Platform Instructions 22 of 27

23 2.If they use different terminology 2.Please only select options from the drop-down 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 C Closed by sponsor Drop Down D Sponsor delays Drop Down E Staff availability issues Drop Down F No patients seen Drop Down Version 4.0-Mar CTP Submission Platform Instructions 23 of 27

24 G No patients consented Drop Down H Contracting delays Drop Down I Rare diseases Drop Down J Other Drop Down Comments Free-text 500 character limit Word limit exceeded Reasons for delay correspond to: Drop Down; NHS provider/sponsor/both/ Neither 1.Reasons for delay correspond to: please select from the drop down options Version 4.0-Mar CTP Submission Platform Instructions 24 of 27

25 ERROR MESSAGES AND VALIDATION FOR PD Data Field Data Requirement Possible Error Validation 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 (2000 characters) If field is blank Please enter the Name of Trial (up to 250 characters) Target number of patients available Drop Down; Available/No target agreed with sponsor 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 Target number of Patients Numeric up to 5 digits 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.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 Version 4.0-Mar CTP Submission Platform Instructions 25 of 27

26 number Date Agreed to recruit target number of patients available Drop Down Agreed/No date agreed with sponsor 1.Field left blank 2.Field with other terminology 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/withdra wn 1.Field left blank 2.Field with other terminology 1.Please indicate Trial status 2.Trial status: please select from the dropdown options Version 4.0-Mar CTP Submission Platform Instructions 26 of 27

27 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 dropdown options Comments Currently free-text 500 character limit Only exceeding character limit Word limit exceeded Version 4.0-Mar CTP Submission Platform Instructions 27 of 27