MTN 003 Training

1. MTN 003 Training DataFax Overview and CRF Completion

2. Presentation Topics • DataFax overview • CRF completion • Standard CRF elements • Data corrections/additions • Handling missing/unknown data • Review and faxing of CRFs

3. What is DataFax? • A data management software system that integrates fax and computer technology. • Allows SCHARP to receive electronic images of completed CRFs from sites. • Allows original CRFs to remain at the sites.

4. What Happens to Data Received at SCHARP? • DataFax “reads” incoming DataFax forms using Intelligent Character Recognition. • It identifies the study to which EACH page belongs, and enters data into the study database. • Each page of data is reviewed by at least 2 people at SCHARP. • Quality Control (QC) issues are identified. • A summary of the QCs is sent to sites on a regular basis. • These are called “QC Reports.”

5. DataFax Split Screen DataFax data record Faxed image

6. Title (CRF Acronym) Study Barcode Visit Code Participant ID Visit/Form Date CRF Margin CRF Margin Staff Initials/Date Issue Date A DataFax CRF

7. Presentation Topics • DataFax overview • CRF completion • Standard CRF elements • Data corrections/additions • Handling missing/unknown data • Review and faxing of CRFs

8. Instructions for DataFax Form Completion • Use either black or dark blue ballpoint pen. • Legibly print written responses or comments. • Always record data by hand (do not use a typewriter). • Do not obscure, mark, hole punch, or damage barcodes in the top margin.

9. Instructions for DataFax Form Completion, cont. • Record data on front side of forms only. • Always record data directly onto forms, do not attach notes. • Never use correction fluid/tape (“White Out”). • Do not copy forms (photocopy or hand-copy) • There should only be ONE copy of a completed CRF at the study site.

10. Instructions for DataFax Form Completion, cont. • Do not record data or make marks in the 1/2 inch (1.3 cm) margin that surrounds each page.

11. How to Mark Response Boxes • Mark the box clearly with an ‘’. Do not shade in the box or mark it with any other character. • Use the entire box to mark your answer. Correct: Incorrect:  • Mark only one box unless instructed to “Mark all that apply.”

12. This is incorrect and would result in a QC note. 0 0 8 8 The 4 may be misinterpreted as a 7 or a 1 because DataFax reads inside the box. How to Record Numbers • Right justify ALL numbers and fill in all blank boxes with zeroes. CORRECT:INCORRECT: • Write each digit within the boundaries of the boxes, but as large as possible. CORRECT:INCORRECT:

13. For example: October 27, 2009 is recorded as: 2 7 O C T 0 9 How to Record Dates • All dates on the CRFs use the format “dd MMM yy,” representing a 2-digit day, a 3-letter month, and a 2-digit year (last 2 digits). • The 3-letter codes for the months are the first 3 capitalized letters of the month.

14. How to Record Time • Use the 24-hour clock • The range is 00:00-23:59 For example, 2:25 p.m. is recorded as: Note: Midnight is recorded as 00:00 not 24:00

15. Item 12a is left blank How to Follow Skip Patterns • Answer all questions in the order they are printed unless instructed otherwise by skip patterns. For example, some forms use skip patterns:

16. Questions about MTN 003 Form Completion When you have a question about how to complete a particular item on a CRF, the first thing you should do is……. Review the form-specific completion instructions on the back of the form to see if there is an instruction that answers your question.

17. Questions about MTN 003 Form Completion If the form instructions do not answer your question, the next thing you should do is……. Contact the SCHARP Project Managers (Karen and Laura) with form completion questions.

18. Presentation Topics • DataFax overview • CRF completion • Standard CRF elements • Data corrections/additions • Handling missing/unknown data • Review and faxing of CRFs

19. Standard CRF Elements:Participant IDs (PTIDs) • SCHARP provides each site with a list of PTIDs before the start of the study (PTID-Name Link Log). • PTIDs assigned at screening, ideally, should be assigned in sequential order (but ok if not) • After a participant signs or marks the informed consent for screening, she is assigned the next available PTID on the list. • Each PTID must be used only once. • If a participant rescreens, use same PTID originally assigned to her at her first screening attempt

20. Participant ID Site Number Participant Number Chk Site Number: assigned by SCHARP Check Digit: ensures accuracy of PTID recorded on the form Participant Number: unique to each participant Standard CRF Elements:Participant Ids (PTIDs), cont. Format of PTIDS: XXX-YYYYY-Z

21. Standard CRF Elements:Visit Codes • A visit code identifies the visit at which the data were collected. • Visit code boxes are usually printed in the upper right corner of a CRF. • In MTN 003, the visit code is 3-digits. Format of visit codes: # # #

22. Standard CRF Elements:Visit Codes, cont. • SSP Section 14 has a detailed list of the MTN 003 visit codes. • When visit code boxesAREon the form, a visit code must be recorded. • When visit code boxesARE NOTon a form, the visit code has beenautomatically assigned. • An example of a form that will NOT have visit code boxes is the Enrollment form, as this form is used only once for each enrolled participant.

23. Standard CRF Elements:Visit Codes, cont. • Scheduledvisits: use whole numbers Scheduled Visit 2 0 0 Visit Code . • Interim visits: will be covered when we talk about follow-up visit scheduling

24. Page Standard CRF Elements:Visit Codes, cont. • On some forms, instead of a visit code, there are boxes to record page numbers. • This is the case for the Concomitant Medications Log, Adverse Experience Log form, and Product Hold/Discontinuation Log, for example. Note: For the AE Log form, the page number recorded will be 3-digits.

25. Standard CRF Elements:Staff Initials and Date • Every DataFax and non-DataFax form includes a line where staff members must record their initials and the date on which the form was completed. • This line is usually printed in the lower right corner of a CRF.

26. Presentation Topics • DataFax overview • CRF completion • Standard CRF elements • Data corrections/additions • Handling missing/unknown data • Review and faxing of CRFs

27. Data Corrections and Additions • ALL changes and corrections must be made on the ORIGINAL form. • Never complete a form as a replacement unless instructed by SCHARP. • Initial and date ALL changes (corrections and additions). • If a change is made on one page of a multi-page DataFax form (e.g., one of the behavioral assessments), only re-fax the updated page.

28. Examples of Data Correctionsand Additions • If a change, correction, or written mark is added to a numeric data box, draw a single line through the incorrect (original) entry, write the correct response near the box, and initial and date the correction. For example: 4 5 KP 01-OCT-09

29. Examples of Data Correctionsand Additions, cont. • Another example… CORRECT:INCORRECT: 4 4 0 5 0 5 KP 01-OCT-09 KP 01-OCT-09 4 04 0 5 0 5 KP 01-OCT-09 KP 01-OCT-09

30. Examples of Data Correctionsand Additions, cont. • If an ‘’ is marked in the wrong box… • draw a single line through the incorrectly marked box • mark the correct box • then initial and date the correction. For example: study site yes no OR KP 01-OCT-09 X X participant’s residence KP01-OCT-09 participant’s workplace home of friend/relative

31. Examples of Data Correctionsand Additions, cont. • If the correct answer has previously been crossed out… • draw a single line through the incorrectly marked box • circle the correct box • write a brief explanation to indicate the correct answer, • and then initial and date the correction. For example: yes no  KP 02-OCT-09 KP 01-OCT-09 Should be YES

32. Presentation Topics • DataFax overview • CRF completion • Standard CRF elements • Data corrections/additions • Handling missing/unknown data • Review and faxing of CRFs

33. J U N 0 8 Handling Missing & Unknown Data • If an answer is unknown, not available, or the participant refuses to answer, draw a single line through the blank boxes and then initial and date the item. • You can also write “don’t know” or “refuses to answer” near the item. For example, the participant cannot remember the exact day she started taking a medication: don’t know KP 01-OCT-09

34. Presentation Topics • DataFax overview • CRF completion • Standard CRF elements • Data corrections/additions • Handling missing/unknown data • Review and faxing of CRFs

35. Reviewing DataFax Forms • Before faxing, site staff must review EACH CRF to check that it is complete, accurate, and all writing is clear. • It is helpful for a second person to review the CRFs.

36. Reviewing DataFax Forms, cont. • Check for common errors: • Missing dates, visit codes and/or staff initials/dates • Incorrect PTIDs or visit codes • Missing, inconsistent, or discrepant data • Changes that have not been initialed and dated • Incorrect screening and/or enrollment forms (from prior, unsuccessful screening/enrollment attempts, if any)

37. Faxing DataFax Forms • Only fax DataFax forms • CRFs with a barcode at the top of the page • Non-DataFax forms should not be faxed to SCHARP • Non-DataFax forms must be kept in the participant’s study notebook • For example, the Physical Exam form

38. Faxing DataFax Forms, cont. • Fax forms for enrolled/randomized participants only. • Fax screening forms from successful screening attempt only • Fax forms to SCHARP DataFax ideally within 1-2 days following the visit (although up to 5 days after the visit is acceptable) • AE Log forms are a priority for faxing • Always re-fax a page when a change has been made

39. Faxing DataFax Forms, cont. • Case report forms can be transmitted to SCHARP in one of two ways: • 1) Faxed using a fax machine connected to a land phone line (fax to phone number +1-206-667-4805) • 2) Faxed using a fax machine connected to the internet (fax to email datafax@scharp.org) • See SSP Section 14 for more information

40. Any Questions?