1Contact Details2Data description3Use of data during the study4People5At the end of the research6Additional information7Approvals Name of Study:* Chief Investigator (CI)* Mr.Mrs.Miss.Ms.Dr.Prof. Prefix First Last Planned Study End DatePlease use the date picker to confirm when the research is due to be completed;* DD slash MM slash YYYY Approved Study Data Managers (DM)*Approved Study Data Managers (DM):* *The Clinical School expects Data Managers to have completed the UIS Cyber Security Training and the University Data Protection Training Module . Please add all data managers applicable to the study. If there is more than one, select the ‘+’ icon to add a new row;Full name:CRSID (Raven username):Data Training Completed? *Date of training (if applicable) YesNo Other users requiring access to the SDHS study dataPlease add the details of all additional users (other than the Data Managers named above) who will be accessing during the study. If there is more than one, select the ‘+’ icon to add a new row;Full name:CRSID (Raven username):Data Training Completed? *Date of training (if applicable) NoYesFirst ChoiceSecond ChoiceThird Choice Designated Point of ContactPlease advise who should be contacted if there are queries pertaining to this request* Prefix Mr.Mrs.Miss.Ms.Dr.Prof. First Last Contact Email* Enter Email Confirm Email Contact phone numberName of person completing this request if different to aboveName of person completing this request if different to above First Last Role of person completing request Please answer the following questions to help us confirm that the Secure Data Hosting Service provides a suitable environment for the requirements of the study; 1. Is this a request to store sensitive personal data for a new research proposal or a change to an existing research proposal to extend the original data storage requirements?*New proposalChange to an existing research proposal2. Have you already produced a data management plan?*NoYesPlease upload a copy of the plan here*(doc, docx, docm, pdf, odt, rtf, zip acceptable) Drop files here or Select files Accepted file types: doc, docx, docm, pdf, odt, rtf, zip, Max. file size: 8 MB. Type of Data3. What type of data do you wish to store?3a. Text*Please select ‘Not applicable’ or the Text type(s) you wish to store. If multiple options apply keep selecting until all those that are relevant are listed. If not listed choose ‘other’. Not applicableWordExcelAccessOtherYou selected 'other'; Please key in the additional Text type(s) below.* 3b. Images*Please select ‘Not applicable’ or the Image type(s) you wish to store. If multiple options apply keep selecting until all those that are relevant are listed. If not listed choose ‘other’. Not applicablePDFJPEGGIFOtherYou selected 'other'; Please key in the additional Image type(s) below;* 3c. Audio files*Please select ‘Not applicable’ or the Audio file type(s) you wish to store. If multiple options apply keep selecting until all those that are relevant are listed. If not listed choose ‘other’. Not applicableWAVMP3OtherYou selected 'other'; Please key in additional Audio File type(s) below; 3d. Film*Please select ‘Not applicable’ or the Film type(s) you wish to store. If multiple options apply keep selecting until all those that are relevant are listed. If not listed choose ‘other’. Not applicableFLACMP4OtherYou selected 'other'; Please key in additional Film type(s) below;* 3e. Other file typesPlease record any other data file types you wish to store in the space below.4. Please provide total data size to be stored* Data Source5. Compliance related to the data source5a. Where is the data you wish to store coming from?*Please select one or both options as required.Directly from study participantsFrom / via a third party5b. Please confirm the details of the third party/parties who will sending the data, e.g. NHS Digital, Public Health England etc.;*5c. Is there a Data Transfer Agreement (DTA) / Data Sharing Agreement or other supporting evidence of compliance / rules, in place to cover transfer of data sets between different establishments?NoYes5d. Did the DTA / Data Sharing Agreement originate with a third party, rather than University of Cambridge?YesNo5e. Has the DTA / Data Sharing Agreement been reviewed by the Contracts Team within the Research Office?YesNo6. Are there known compliance requirements (legal or regulatory) related to receiving this data e.g. NHS Toolkit, GDPR etc.*Please confirm what these are or type ‘none applicable’;7. How is the data to be transferred and loaded?*Please provide a brief summary below; 8. Extraction of data8a. Does the research require extraction of data out of the secure data hosting service, during the research?*YesNo8b. In what format do you propose to extract the data?Please select all that apply. If not listed choose ‘other’.CSV (Comma separated variables)PSV (Pipe separated variables)TAR (Tape ARchive)GPX (GPS Exchange format / XML)OtherYou selected 'other'; Please key in below. 8c. Are you proposing to encrypt the extracted data?YesNoConfirm the encryption method 8d. What purposes is the data to be extracted for?9. Data analysis9a. Do you need to conduct analysis of the data using specific tools or methods?*NoYes9b Which analysis method/ application are you planning on using?Select all that apply. If the method is not listed select ‘other’.SASSTATAOtherYou selected 'other'; Please key in additional analysis methods you plan to use below; 9c. Are you planning on conducting this analysis from within the SDHS environment?YesNo10. Printing10a. Do you need to print data from the secure data store?*10a. Do you need to print data from the secure data store?NoYes10.b Please confirm the following security conditions can be met;Hold down CTRL and select all that apply;Printer is networked and managed by CSCS with a print queue in the CSCS print serverEach person requiring print capability is namedPrinter is located in a physically secure location, not a public area, e.g. limited swipe card access11. Internet access11a. Do you need to access the internet from within the SDHS?*11a. Do you need to access the internet from within the SDHS?NoYes11b. What resources/websites are required?Please list below; 12. People12a. How many people do you expect will require access during the period of the study?* 12.b. From where will users be logging in to gain access to the data?*PC on University premisesAt HomeElsewhereYou selected 'Elsewhere'; Please specify where else users will be logging in to gain access to the data;12c. Does research involve non-UK based individuals, with differing security standards or legal requirements that we must adhere to?*NoYesPlease provide details of non-uk based people or teams involved;12d. Will individuals accessing data potentially need to change over the course of the research / period of data storage?*NoYesPlease provide details as to why those involved in the research may change 13. Data disposal13a. Is all the data to be disposed of at the end of the research?*NoYes13b. Has a preferred method of deletion/disposal been identified?NoYesPlease give details as to the deletion / disposal method13c. Who has the responsibility for completing data disposal13d. Is a Data Disposal Certificate required?NoYes13e. If all data is not to be disposed of has consent been sought from data owners to store the data longer term?YesNo 14. Is there anything else you would like to highlight related to your methods specific to acquiring and / or using Personal Identifiable Data?If in any doubt as to whether your planned approach is standard / compliant, include a basic summary of the end to end PID workflow here; Please upload the following supporting documentationResearch Ethics Committee Approval LetterAccepted file types: doc, docx, docm, rtf, pdf, Max. file size: 8 MB.(doc, docx, docm, rtf, pdf (8MB max)Participant Information SheetAccepted file types: doc, docx, docm, rtf, pdf, Max. file size: 8 MB.(doc, docx, docm, rtf, pdf)Consent FormAccepted file types: doc, docx, docm, rtf, pdf, Max. file size: 8 MB.(doc, docx, docm, rtf, pdf)Research Ethics Committee Application Form (please only attach pages relating to Data Storage)Accepted file types: doc, docx, docm, rtf, pdf, Max. file size: 8 MB.(doc, docx, docm, rtf, pdf)Is the study a Clinical Trial of Investigational Medicinal Product (CTIMP)?Is the study a Clinical Trial of Investigational Medicinal Product (CTIMP)? YesNoIf yes please provide MHRA approval date and CTA PLEASE NOTE: NEITHER THE IGO OR CSCS ARE RESPONSIBLE FOR THE DATA CONTENT. THE CHIEF INVESTIGATOR IS RESPONSIBLE FOR ALL CONTENT AND ENSURING THAT ALL REGULATORY REQUIREMENTS FOR THE DATA ARE ADHERED TO. Confirmation; Reading the policies* I confirm as Chief Investigator that the Secure Data Hosting Policy and SDHS Acceptable Use Policy have been read and understood by myself, the Data Manager(s) and SDHS users associated with this study. Please tick the boxI confirm as Chief Investigator that the https://www.medschl.cam.ac.uk/research/information-governance/sdhs-security-policy/ Secure Data Hosting Policy and https://www.medschl.cam.ac.uk/research/information-governance/sdhs-acceptable-use-form/ Acceptable Use Policy have been read and understood by myself, the Data Manager(s) and SDHS users associated with this study. Please tick the box Confirmation; Compliant use of the Secure Data Hosting Service* I confirm that we agree to use the Secure Data Hosting Service in accordance with these policies. Please tick the boxChief Investigator SignaturePlease upload a saved version of your signature below;Max. file size: 8 MB.Date of signing MM slash DD slash YYYY For further information please contact;Research Governance Office, Clinical School, Box 111, Addenbrooke’s Hospital, Hills Road, Cambridge, CB2 0SP or e-mail; researchgovernance@medschl.cam.ac.uk Δ