1 / 107

Project Specific InForm  Training Chandra Kumar CDS, DCRI

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.

fayre
Download Presentation

Project Specific InForm  Training Chandra Kumar CDS, DCRI

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related