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Project Specific InForm  Training Chandra Kumar CDS, DCRI. Topics Covered. InForm Reminders Subject Enrollment ALMAC IXRS Transfer Study set-up Subject Contact Information for follow-up Visit structure and unique forms Overview of InForm Live DEMO. 2. Reminders.

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Project Specific InForm  Training Chandra Kumar CDS, DCRI


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    1. Project Specific InForm Training Chandra Kumar CDS, DCRI

    2. Topics Covered • InForm Reminders • Subject Enrollment ALMAC IXRS Transfer • Study set-up • Subject Contact Information for follow-up • Visit structure and unique forms • Overview of InForm • Live DEMO 2

    3. Reminders • If more than one person is in the room to attend this training, please send me Chandra.kumar@duke.edu an e-mail indicating who was on the TC with you • eSig forms will be send to you within 48 hours. If you have not received one within that time, contact Carla 3

    4. InForm Access Database 1. After training, each user will receive the trial URL, a username and temporary password. 2. Log in and change temporary password to a private one 4

    5. Password Requirements • Passwords can be changed at any time. • Password length Requirements: 6 - 32 characters. • Passwords are case sensitive, c is different from C. • Passwords are automatically set to expire every 120 days • You will have to re- log in with your username and password after a pre-determined time while working in InForm or after a period of inactivity. Reminder: Three unsuccessful login attempts will cause your account to become inactive. 5

    6. Changing your Password‘As Needed’ To change your password at anytime, select the trial logo box located here 6

    7. System SecurityYour InForm™ Account Training Database: • You will be assigned a user ID and password to the training database • The training database and your access will remain active throughout the trial Production Database: • After successful completion of training, each user will be notified via separate e-mails of their userID and temporary password to the production database • For security reasons, your e-mail must not be a shared account. This is so the temporary password will be secure until you receive it and change it. 7

    8. System Security • 15 minutes • 2 hours • The system will end a session after a period of inactivity of : • The system will end a session after a period of sustained activity : Note: work will not be lost – you will just have to re-enter your username and password 8

    9. EDC Help Desk For password questions or any other questions about the InForm system, please contact the EDCSite Support Help Desk at 1-866-999-3274 OR e-mail: edchelp@mc.duke.edu Hours 8:00am-8:00pm EST Monday – Friday 9

    10. Form and Visit RulerNavigation Through a Visit Visit Ruler Form Ruler Note: - Visit Ruler – Current Visit is highlighted in Yellow - Form Ruler – Current Form is highlighted in Yellow 10

    11. Data Entry – Choices Check box - check all that apply, at least one must be selected Round radio buttons – only one item can be selected 11

    12. InForm Subject Enrollment • When you log into InForm –subjects randomized via ALMAC IXRS will already be present (updated hourly) • ***NOTE: Subjects cannot be enrolled into InForm by site personnel*** • Data from ALMAC IXRS will be present on the following forms: • DEM (DOB, Sex) • RAND (Planned functional test, Date of Rand, Rand arm) • RAND1 – (Randomized arm/functional test) 12

    13. InForm Subject Status from ALMAC • There will be 2 yellow traffic lights at baseline visit (DEM and RAND) • There will also be 1 yellow traffic light at the DIAGTST visit (RAND1) • This is data that has been transferred by ALMAC IXRS • Only the data on DEM is editable 13

    14. Visits • BASE • DIAGTST • 60DAY • CAS 14

    15. BASE Visit • Forms to complete: • Date of Visit (VISIT) • Subject Contact Information (SCI) • Inclusion/Exclusion (ELIG) • Demographics (DEM) • Pregnancy Test (PREG) • Vitals (VITALS) • Cardiac Risk Factors (CRDRSK) • Providers Assessment of Patient Risk (PAPR) • Presenting Symptoms (PS1 and PS2) • Office ECG (ECG) • Diagnostic Laboratory Texting (DXLAB) • Status (STATUS) • Concomitant Medications (CONMED) • Biomarker/Genomics Collection (BMKGEN) • Randomization (RAND) 15

    16. InForm – BASE Visit Forms Present 16

    17. SCI - Subject Contact Information • Should be entered at BASE visit • Data is sent to Follow-up and EQOL group (DOFG) for the follow-up visits • Only DOFG and Sites will have access to this form. • This data will not be available in the dataset for Statistical analysis 17

    18. SCI - Subject Contact Information Questions 1,2,4,6-9 are required to be completed at the screening visit 18

    19. SCI - Subject Contact Information– con’t • Subject Contact Information requested: • Patient information including address, phone numbers, e-mail • Spouse/significant other information including address, phone numbers, e-mail • Secondary address information • Other friend/relative information including address, phone numbers, e-mail • Health care provider information 19

    20. InForm – BASE Visit 20

    21. VISIT – Visit Status Date of Visit is defined as the date the informed consent was signed 21

    22. InForm – BASE Visit 22

    23. ELIG – Inclusion/Exclusion • Indicate all criteria not met • If criteria is answered ‘NO’ – enter the Inclusion/Exclusion criteria # indicated in the protocol 23

    24. InForm – BASE Visit 24

    25. DEM - Demographics • Date of Birth and Sex are editable • Subject Age is calculated by InForm after DOV is entered 25

    26. PREG - Pregnancy Test • Dynamically generated off ‘Yes’ response to able to bear children on DEMOG form • Pregnancy test must be completed in past 30 days for Stress Nuclear and CTA testing 26

    27. InForm – BASE Visit 27

    28. VITALS – Vital Signs Note: For Weight – be careful of units – kg is placed first followed by lbs 28

    29. InForm – BASE Visit 29

    30. CRDRSK – Cardiac Risk Factors Answer YES or NO to each question 30

    31. InForm – BASE Visit 31

    32. Providers Assessment of Patient Risk (PAPR) These questions should be completed by PI prior to the randomized diagnostic test 32

    33. InForm – BASE Visit 33

    34. PS1 – Presenting Symptoms • Source documents are available for collecting this information • Only symptoms that are present are entered in Inform • This is a repeating form – one line for each symptom 34

    35. PS1 – Presenting Symptoms Click ‘New’ to start entry and to add a new row 35

    36. PS1 – Presenting Symptoms Select ‘New’ to enter another symptom 36

    37. PS1 – Presenting Symptoms 1 - Select symptom from drop down box or select ‘other’ and specify condition 2 - Primary symptom: Indicate ‘YES’ for the primary symptom, ‘NO’ for all others ***NOTE: There should be only ONE primary symptom*** 3 – Do not enter duplicate symptoms – if this occurs a query will fire – delete/update that symptom with the query 37

    38. InForm – BASE Visit 38

    39. PS2 – Presenting Symptoms • Question 1 & 2 – Answer for all subjects • Question 3 – Only answer if PS1 indicates: • - Chest pain/pressure – substernal or left anterior • - Chest pain/pressure – other • Queries for PS1 will appear on this form 39

    40. InForm – BASE Visit 40

    41. ECG – ECG Assessment • Enter the results of the most recent ECG performed prior to randomization • If time is not on report – enter UNK 41

    42. InForm – BASE Visit 42

    43. DXLAB – Diagnostic Laboratory Testing • Creatinine – required for all subjects within 90 days of randomization • The remaining tests are not required, but data should be entered if the tests were performed within the past year: • BNP or pro-BNP • hs-CRP • Total Cholesterol • Triglycerides • HDL • LDL • Hemoglobin • Hematocrit • NOTE: The more common unit for some of these tests (Chol, Trig, etc.) may not be the first choice 43

    44. DXLAB 44

    45. InForm – BASE Visit 45

    46. STATUS • Question 1 – If answered YES, ConMed form will appear • Question 2 and 3 – If either question is answered YES, BMKGEN form will appear 46

    47. CONMED – Concomitant Medications Enter only the medications the subject is currently taking Do NOT enter dose/units/frequency/route, etc. next to medication 47

    48. BMKGEN – Biomarker/Genomics • This form is generated from Status form – if either Question 2 or 3 is answered YES • The top of the form captures information on vials/tubes sent to Esoterix • The Accession Number is the 9 digit accession number from the vial label • The bottom section captures specimen collection for biomarker and/or genomics 48

    49. BMKGEN – Biomarker/Genomics • How to find accession number Do not include the labeled item number Accession number – 9 digits 49

    50. BMKGEN – Biomarker/Genomics To enter specific information about sample drawn for biomarker or genomics 50