文本分析原稿4.keri en1500-1530electronic data capture edcdata management

1、1KHB 1801/KHB 1802 PANDA Data ManagementKeri Keiski, Sr. Project Data ManagerIntroductionKeri Keiski Syneos HealthSr. Project Data Manager KHB-1801Based: Newtown, PA USAAgendaData Flow ChartWhat is RAVE?Rave SupportLogin Credentials and Study AccesseLearningCommon IssuesData Entry and Data Status Ic

2、onsPI SignatureRave Dynamics and CRF Overview1802 Unique CRFsData Flow ChartWhat is Medidata Rave?Web-based tool for easy access by all users which allows:The site to enter data and manage discrepancies in real timeAuthorized Sponsor and CRO users to view the clinical data in the study databaseInves

3、tigators to electronically sign or approve eCRFsThe principal reason for using EDC systems is that they enable us to provide cleaner data faster!Rave SupportContact via e-mail or phoneToll free numbers availableAvailable 24/7Multi-lingual Support availableIf you forget your username, contact your CM

4、AIf you forget your password, use the Forgot Password linkLogin CredentialsPasswords are case sensitivePasswords will expire every 90 daysSystem will require you to login again after a 15 minute period of inactivityStudy AccessComplete the iMedidata, RAVE and Module Access Request Form v 3.0 date 12

5、Jun2019Section A: User InformationUser TypeIf SYNH, check InternalIf External, check ExternalActionCheck New Study User Account for all new requests for KHB study.If you have an existing account, ensure the email on the existing account is recordedStudy Access (contd)Section B: PINRequired for ALL u

6、sers6 digits requiredEach user should have their own unique PINSection C: Unmasked RolesRequired to be signed by Unmasked Team Lead (SYNH)Check Section is Not Applicable if Masked role is being requestedStudy Access (contd)Section D: Site AccessAll user requests should have PROD checkedCheck Add for

7、 new usersCheck All Sites in Production - OR - Check Site-Specific AccessEnter Site NumberEnter Site NameStudy Access (contd)Section E: User RolesCheck Add for the appropriate Masked or Unmasked RoleCheck only one roleNote: Unmasked roles have Unmasked in the Role titleStudy Access (contd)Section F:

8、 Security and eSignatureALL users must sign Section FStudy Access (contd)Section G: Business Reporting ToolsONLY SYNH and Sponsor sign Section GIf you are a site user, please leave this section blankStudy Access (contd)Send PDF of signed, completed access form via email to your CMA and the following

9、 mailbox: For 1801 For 1802 In the body of the email please indicate the site number and the role of each user (Research Coordinator or Principal Investigator and specify masked or unmasked)User will receive two (2) emails Secure Access Code email from Study Invitation email from NOTE: Invitation em

10、ail from iMedidata will expire in 30 dayseLearningRole Specific eLearning must be completed before access is given to the study (i.e. CRC, PI, etc.) *Note passing score is 80%Study Access eLearning is required by all users Module verifies that correct user is logging inNote: If Role Specific eLearni

11、ng utilizing iMedidata has already been completed, it does not have to be completed again. Please provide copies of eLearning training certificates to your CMA/CRA and file in the Investigator Site File (ISF) BinderCommon IssuesEnsure that you are using Internet Explorer V9 or higherEnsure pop-up bl

12、ockers are turned offIf you did not receive the Study Access Code email:Check junk/spam email folderAdd to address bookContact CMA/PDM to ensure access has been processed and to have access code resentIf you did not receive the Study Invitation email:Check junk/spam email folderAdd to address bookCo

13、ntact CMA/CRA/PDM to ensure access has been processed and that email address was correct (99% of issues are due to incorrect email addresses)Data EntryeCRFs are to be completed by sites within 2 business days of visit and according to the eCRF Completion Guidelines providedOpen queries are to be ans

14、wered/addressed within 2 business days of being issuedData fields are to be updated before query response is enteredDo not use special characters within a data field. This will cause problems in the dataData Status IconsData Status Icons appear next to each data field on the eCRF and let you know th

15、e status of the particular data fieldClicking on the data status icons will allow you to view the Audit Trail for that data fieldPI SignatureBatch Signing via the Grid View1: Navigate to the Subject homepage2: Click the Grid View link on the upper-right corner of the main area3: Click the Form Name

16、or Folder Name that requires signature, or click All to select all Forms and Folders4: Enter your Username and Password and click SaveReminder: PI access must be obtained and retained in order to complete PI signature when requiredPI Signature (contd)Signing via Subject Homepage1: Navigate to the Su

17、bject homepage2: Click on the Sign and Save3: Enter Username and Password21Rave Dynamics & CRF OverviewEnrollmentEnrollment CRF will contain the Subject ID which is integrated from IXRS and will not be entered by the siteScreeningScreening folder will consist of all necessary forms at the screening

18、visitInformed ConsentAdd a new log line for every re-consent to a new protocol versionInitial entry, select Informed Consent for initial consentInformed Consent - SubstudyInitial entry, select Substudy Informed Consent initial for initial consentSelecting Yes and appropriate substudy checkbox will p

19、opulate substudy formsInclusion/Exclusion Criteria8 Inclusion Criteria27 Exclusion CriteriaEnsure all items are answeredEnsure all items are answered by using the scrollScreen FailureIMPORTANT DYNAMIC: Selecting No on the Screen Failure CRF will populate ALL forms at Day 1 VisitRandomization (masked

20、)Randomization - UnmaskedIntegrated from IXRS and only visible to unmasked user rolesRandomization NumberRandomization DateRandomization TimePrimary/Secondary EndpointsPrimary EndpointBCVA by ETDRSSecondary EndpointsBCVA by ETDRSSD-OCTBlood Sampling PK - SubstudyImmunogenicity - SubstudyPost-Injecti

21、on Safety AssessmentBCVA by ETDRSCylinder Value and Axis is only required if Cylinder is + or -Auto-Calculated from entered # of letters read correctlySD-OCTEnsure that the SD-OCT is sent to the reading center if applicableEnter data for Right Eye click Save and then Enter Data for Left EyeBlood Sam

22、pling PK/Immunogenicity - SubstudyPost-Injection Safety ChecksIf any findings are considered an AE, record on the AE CRF in a MASKED fashion and select corresponding AE from the drop down menuTreatment Administration - UnmaskedStart Time of Prep = Time removed from refrigeratorCompletion Time of Pre

23、p = Time IP is injected Kit Number & Ancillary Number administered will be reconciled with Kit number assigned and ancillary number assigned from IXRSIntraocular Pressure Post Injection - UnmaskedIf Yes is selected record AE in a MASKED fashion on AE CRF and select corresponding AE(s) from the dynamic s