Section 11. Data Collection
Contents
1. 00 a m 10 00 10 00 p m 22 00 11 00 a m 11 00 11 00 p m 23 00 11 2 6 Data Corrections and Additions Sometimes data on a DataFax CRF may need to be changed clarified or amended There are many reasons why data may need to be changed such as in response to a QC report or as a result of site review of the CRF before faxing It is important to make these changes to the original CRF never copy data onto a new form After making the change the CRF must be re faxed to DF Net Research DataFax Note If a correction or addition is made to one page of a multiple page CRF only refax the page that was changed Initial and date all changes or additions Note Never write over an entry once it is recorded Use the standards outlined in the following paragraphs when changing clarifying or amending data Whenever an entry on a DataFax CRF is changed do the following draw a single horizontal line through the incorrect entry do not obscure the entry or make it un readable with multiple cross outs place the correct or clarified answer near the box and initial and date the correction as shown below Correct Incorrect A pop L ot 22 NOV 10 ae If an X is marked in the wrong response box correct it by doing the following draw a single horizontal line through the incorrectly marked box mark the correct box and MTN 028 SSP Manual Version 1 1 18 August 2015 Section 11 11 9 initial and date th2. 12 cycle The spreadsheet requires that the participant s Enrollment date be entered Once the enrollment date is entered the target days and visit windows for follow up visits through Day 28 will appear The remaining study visit target days and visit windows will depend on the actual date of each participant s Day 28 visit There are no visit windows around Days 1 2 29 and 30 as these are daily visits The calendar can be printed added to the participant s study notebook and updated as needed Split Visits For MTN 028 Enrollment Visits may not be split Whenever possible all required follow up visit evaluations should be completed on the same day In those cases where this is not possible the participant may come back and complete the remaining evaluations on another day as long as that day is within the allowable visit window For example a participant comes in on Day 35 to complete the Final Clinic Visit and completes all of the required evaluations but has to leave prior to completing a blood draw for safety labs She comes back the next day on Day 36 and completes the remaining required procedures This is allowed and is referred to as a split visit as the participant completed all required visit evaluations on two separate days both days being in the visit window Note that for split visits only one Follow up Visit Summary CRF is completed and all CRFs completed for the visit are assigned the same visit code The
3. 3 4 Staff Initials Date Most forms include a line in the lower right corner for a staff member s initials and the date on which the form was completed When more than one staff member records data on a CRF the site should designate the staff member who has primary responsibility for the form This individual completes the staff initials date field The individual not identified in the staff initials date field writes his her initials and date next to each data element for which he she is responsible 11 3 5 Form Supply Sites are responsible for creating their own supplies of MTN 028 case report forms Sites should print CRFs from pdf files provided by SCHARP available on the MTN 028 Atlas web page CRF pdf files will include visit packets pdfs containing all of the CRFs required to be completed for the visit as well as a pdf file containing all of the CRFs created for the study Site are encourage to test and make sure the CRFs they have produced can be read into DataFax by using a test fax pdf provided by DF Net Research A test fax should be done each time new printing photocopying or faxing equipment is installed or modified and also when paper used for CRFs changes 11 3 6 Case Report Form Completion Schedule The provided forms for this study include DataFax forms forms that are completed and faxed to DF Net Research DataFax and non DataFax forms forms that are completed but not faxed to DF Net Research DataFax Some DF Net
4. FEB August AUG March MAR September SEP April APR October OCT May MAY November NOV December For example June 6 2015 is recorded as 0 6 JUIN 1 5 dd MMM yy MTN 028 SSP Manual Version 1 1 18 August 2015 Section 11 11 7 Sometimes only a month and a year are required e g diagnosis date for a pre existing condition in which case the response boxes will look like this ar A diagnosis date of October 2015 would be recorded as follows MMM yy o c T 1 5 11 2 5 How to Record Time Time is recorded on DataFax CRFs using the 24 hour clock 00 00 23 59 in which hours are designated from 0 23 For example in the 24 hour clock 2 25 p m translates to 14 25 2 p m 14 which would be recorded as follows TH Midnight is recorded as 00 00 not 24 00 The following chart shows equivalencies between the 12 and 24 hour clocks 12 hour clock 24 hour 12 hour 24 hour a m clock clock p m clock Midnight 00 00 Noon 12 00 1 00 a m 01 00 1 00 p m 13 00 2 00 a m 02 00 2 00 p m 14 00 3 00 a m 03 00 3 00 p m 15 00 4 00 a m 04 00 4 00 p m 16 00 5 00 a m 05 00 5 00 p m 17 00 MTN 028 SSP Manual Version 1 1 18 August 2015 Section 11 11 8 6 00 a m 06 00 6 00 p m 18 00 7 00 a m 07 00 7 00 p m 19 00 8 00 a m 08 00 8 00 p m 20 00 9 00 a m 09 00 9 00 p m 21 00 10
5. Visit Date on the Follow up Visit Summary CRF is the date of the first part of the split visit See Section 11 3 3 for more information on assigning visit codes to split visits Table 11 1 Visit Timing Requirements MTN 028 study visit schedule Visit code Visit type target day Visit Window 1 0 Screening Visit lt 45 days n a 2 0 Enrollment 0 45 days after Scr 3 0 Day 1 1 Same as target day 4 0 Day 2 2 Same as target day 5 0 Day 3 3 Days 3 5 6 0 Day 7 7 Days 6 8 7 0 Day 14 14 Days 13 15 8 0 Day 21 21 Days 20 22 9 0 Day 28 28 Days 27 29 10 0 Day 29 1 day after visit 9 0 Same as target day 11 0 Day 30 2 days after visit 9 0 Same as target day 12 0 Day 31 3 days after visit 9 0 2 after target day 13 0 Day 35 Final Clinic Visit 7 days after visit 9 0 1 day around target day MTN 028 SSP Manual Version 1 1 18 August 2015 Section 11 11 13 Missed Visits In those cases where a participant is not able to complete any part of a required follow up visit within the visit window the visit is considered missed For example an enrolled participant does not report to the clinic for her Day 2 Visit Per table 11 1 this visit has been missed The missed visit is documented in the study database by completion of a Missed Visit CRF that is faxed to DF Net Interim Visits An interim visit occurs when there is a contact with the participant but required follow up visit procedures are not done because the required follow up visi
6. site please contact the SCHARP Project Manager and the team at kronos dfnetresearch com For questions or technical assistance with iDataFax please contact the SCHARP Project Manager and the team at support dfnetresearch com 11 2 DataFax Form Completion 11 2 1 General Guidelines Based on the use of fax technology and Good Clinical Practices GCPs the following guidelines should be used for completing DataFax CRFs Use a black or dark blue medium ballpoint pen Do not use any other type of writing tool Use only one color per form That is do not begin completing a form using a blue pen and then switch to a black pen during the same form completion session Press firmly when recording data or writing comments Print all data and comments legibly by hand Entries that cannot be read will result in QC notes Do not type data onto CRFs Do not use cursive script handwriting as it can be difficult to read Write numbers as large as possible while staying within the boundaries of the boxes Record data on the front of CRFs only DataFax cannot read the back of CRFs Do not record data or make marks in the 0 5 inch 1 5 cm margins at the top bottom or sides of the CRF If the lines provided for written responses are not long enough continue in another blank area of the form within the page margins Mark only one answer except when given the instruction Mark all that apply A response is required for every
7. to recall the complete date of last menstrual period obtain participant s best estimate At a minimum the month and year are required Only record dates of menstrual period bleeding including expected monthly bleeding on oral contraceptive pills If a participant has not had a menses in the past 30 days mark none If the participant is currently on her menses mark ongoing In these cases this item does not need to be updated with a stop date once known at a later visit Pharmacokinetics Specimens Day 28 PKS 1 and Pharmacokinetics Specimens Days 1 2 3 7 14 21 29 30 31 35 PKD 1 In item 1 record the start and stop dates of the last vaginal bleeding that the participant experienced This includes menstrual period bleeding withdrawal bleeding and expected breakthrough bleeding experienced while the participant is on Depo Mirena or other continuous contraceptive method where a women does not experience a monthly menstrual period If a participant has not had any vaginal bleeding in the past 30 days mark none If the participant is currently bleeding at the time of the study visit mark ongoing This item does not need to be updated with a stop date once known at a later visit If silver nitrate monsels solution is used to stop bleeding during the collection of cervical biopsies this should be noted in the comments section of the PKS to better inform PK analyses of the vaginal swabs collected on Day 2
8. with zeroes If boxes are left blank a QC note will be applied asking for the boxes to be filled in The following example shows how a value of 7 is recorded when three response boxes are provided Correct Incorrect 00 7 This example would result in a QC note e Write the number s as large as possible while staying within the boundaries of the box try not to stray outside the boundaries of the box In the following example the 4 could be misinterpreted as a 7 or a 1 because DataFax can only read what is inside the box Correct Incorrect ul e Write the number s simply with few loops The following example shows the format in which numbers will be most easily read by DataFax Also included are some commonly used formats that may be difficult for DataFax to identify MTN 028 SSP Manual Version 1 1 18 August 2015 Section 11 11 6 Easily Identified 0 M 2 3 H B l Z 8 9 Difficult to Identify 11 2 4 How to Record Dates Dates are recorded using the dd MMM yy format where dd represents the two digit day MMM represents the three letter abbreviation of the month in capital letters and yy represents the last two digits of the year The month field must be filled in with the three letter abbreviation in English for the date to be read in DataFax Abbreviations are shown in the table below Month Abbreviation Month Abbreviation January JAN July JUL February
9. 2 8 Non DataFax Forms Non DataFax forms are case report forms that are used for data documentation purposes but are not faxed to DF Net Research These forms are created to ensure consistent and accurate data documentation across study sites for data that is not needed in the study database Non DataFax form is easily identifiable because there is no DataFax barcode along the top of the CRF In place of the barcode the following text appears NOT A DATAFAX FORM DO NOT FAX TO DATAFAX Non DataFax forms are completed using the general guidelines presented above and completed forms are stored just as DataFax forms in participant files binders MTN 028 SSP Manual Version 1 1 18 August 2015 Section 11 11 10 11 3 11 2 9 Faxing DataFax Forms Each CRF with a bar code at the top is a DataFax form and is faxed to DataFax once completed and reviewed as described in the site s MTN Data Management SOP Sites are encouraged to develop a system that identifies each time a form page is faxed so that re faxing of unchanged forms can be avoided A date stamp used on the back of the form page may be used for this purpose as long as the date stamp does not obscure data recorded on the front of the form page 11 2 10 Form Storage Specifications for form storage are described in the site s MTN Data Management SOP It is recommended that for each participant study CRFs be stored in a hard cover notebook with a tabbed section for CRFs completed at e
10. 8 Document this medication on the concomitant medications log CRF MTN 028 SSP Manual Version 1 1 18 August 2015 Section 11 11 19 Concomitant Medications Log CM 1 e When recording injections e g Hepatitis B vaccine Depo Provera record each injection as its own separate entry The Date Started and Date Stopped dates should be the same date Mark the once box for Frequency and the appropriate box for Route e g IM or Other for subcutaneous injections e Recreational drugs should not be reported as concomitant medications for this protocol Clinical Product Hold Discontinuations log PH 1 e If no hold continuing at the Day 28 visit is marked in Item 4 record the date that the Day 28 visit 9 0 visit was completed If the Day 28 visit is missed record the target date of the Day 28 visit per the participant s visit schedule If the reason for the hold later meets criteria for permanent discontinuation between the participant s Day 28 visit and her date of termination update the response in Item 4 to no permanently discontinued and record the date the reason first met criteria for permanent discontinuation e If no permanently discontinued is marked in Item 4 record the date that the reason in Item 2 met criteria for permanent discontinuation This date could fall anytime between the participant s enrollment visit up through her Termination date Pe
11. F is received at DF Net Research Therefore it is very important that the site refax updated CRF pages to DF Net Research DataFax any time a change is made to a CRF regardless of whether or not the change was made in response to a QC report 11 1 3 iDataFax View only Access Each site will be able to access and view its own MTN 028 CRF data via iDataFax view only access With view only access sites can view their faxed CRF images and data view their QCs and clinical queries identify missing CRF pages or visits and export their data This will allow the user to review and resolve QCs even before they can be included on a QC report Being able to see the CRF image and what is in the database can also help the user to better understand what needs to be modified or reported on the paper CRF to resolve the QC or query NOTE View only access means that the user can view what s in iDataFax but cannot enter or modify data or respond to QCs or clinical queries In addition sites will not be able to view or access other sites data To obtain view only access to its study data each site must first download the iDataFax software by logging into the DF Net Research Kronos web site https kronos dfnetresearch com Each Site Coordinator will be set up with a Kronos and iDataFax user account prior to study start As each new user account is set up the user will receive a Welcome to the Kronos Web Site new user registration e mail from the
12. Research provided forms are required to be completed at each visit while other forms are required only at one visit or only when specifically indicated The following table Table 11 3 lists the DataFax and non DataFax forms that are required to be completed at each study visit MTN 028 SSP Manual Version 1 1 18 August 2015 Section 11 11 16 Table 11 3 Schedule of Forms CRFs Required to be Completed at Each Visit Visit 1 Screening Visit Visit Code 1 0 DataFax forms Non DataFax forms Concomitant Medications Log Pelvic Exam Diagrams Demographics Eligibility Criteria Pelvic Exam Pre existing Conditions Physical Exam Safety Laboratory Results Visit 2 Enrollment Visit Visit Code 2 0 DataFax forms Non DataFax forms Enrollment Pelvic Exam Diagrams Physical Exam Pelvic Exam Pharmacokinetics Specimens Enrollment Safety Laboratory Results Specimen Storage Visit Day 1 2 3 7 21 Visit Codes 3 0 8 0 DataFax Forms Non DataFax forms Follow up Visit Summary Pelvic Exam Diagrams Physical Exam Pelvic Exam Pelvic Exam Ring Assessment Pharmacokinetics Specimens Days 1 2 3 7 14 21 29 30 31 35 Ring Adherence At Visit 5 0 Day 3 only Specimen Storage Visit Day 28 Visit Code 9 0 DataFax forms Non DataFax forms Follow up Visit Summary Pelvic Exam Diagrams Pelvic Exam Pelvic Exam Ring Assessment Physical Exam Pharmacokinetics Specimens Day 28 Ring Ad
13. Section 11 Data Collection 11 1 Daal ax Ove Wi accdnet cchasretcant eh aa lt tu a a a a a a a E aesa 11 2 11 1 1 CRF Transmission and Troubleshooting s ssssssssessseeeeseeesesesrsrsrnsntsesesssrsrsrenenenesesrsrsesnsnes 11 2 11 1 2 Data Entry Quality Controli eia aeee deea a tl oo a ed a 11 3 11 1 3 iDataFax View only ACCES Sinnen aniani a eve ania ie 11 3 11 2 DataFax Form Completion noran a R A A E R 11 5 11 2 1 G neral Guidelines miren e aa E EA E E A E A betes 11 5 11 2 2 How to Mark Response BoXES csccescsssesscesecseeeseeseceaesseseecaecaeseeeeaecaeeeaeseecaeeaeseeseaeeaeeas 11 6 11 2 3 How to Record NUMDEfS sossen a e a E a a a 11 6 11 2 4 HOW tO Record Dates z eiea e a E E e A A a E ies E 11 7 11 2 5 Flow to Record TIME asese e E E E cate E a A E a aii 11 8 11 2 6 Data Corrections and Additions wscsstscosniresetesecvonsestnes nn ches teas cshioto Geastuasces esta d oaVoadavaecedeerenies 11 9 11 2 7 How to Handle Missing and Unknown Data lt lt c0 cccsevasessasceneetecnesnesdecteviesnuaatesavesaenones sevens 11 10 11 2 8 Non Datak ax ROMS tenerae rE ciseovs covesacs E A AE E Sete ovens 11 10 11 2 9 Faxi ng DataFax Fr OLIN noni o nenna ea a cd eet TEE AO EEEE a 11 11 11 2 10 Fom Storageiseae ne a a a a E wee Sie Gre mene 11 11 11 2 11 MTN Data Mariage mientS OP ose scescroinos dove pr eoerenseuerceones tases eee eee hoven cp eeerems nate 11 11 11 3 Study specific Data Collection as5 5 5s seven coarse crews cas
14. ach study visit It is suggested that log forms such as the Concomitant Medications Log Adverse Experience Log Clinical Product Hold Discontinuation Log Social Impact Log and Protocol Deviations Log be kept in their own tabbed sections within the participant study notebook This makes page numbering and updating of these forms easier than if these forms are stored by visit within the participant s study notebook 11 2 11 MTN Data Management SOP As a condition for study activation each study site must have an SOP for MTN Data Management This SOP should be reviewed and followed in combination with the information contained in the study protocol this SSP Manual and the site s Clinical Quality Management Plan CQMP The MTN Data Management SOP contains information on and outlines site staff responsibilities for several data topics including Participant ID PTID assignment Participant study file organization Participant confidentiality Site data quality control QC processes Timing of DataFax form data transmission Data QC processes Data storage Study specific Data Collection 11 3 1 Participant ID numbers PTIDs DataFax uses a unique participant identification number PTID to identify each study participant in the database Prior to study start SCHARP provides each site with a list of PTIDs to be used for the study in the form of a study specific MTN PTID Name Linkage Log The site assigns one PTID to each partici
15. ataFax CRFs are being reviewed it is important that they are stored and tracked systematically 11 4 Form specific Completion Instructions Detailed form completion instructions for each form are provided on the back of each form page Some items on forms are straightforward and do not require specific instructions Therefore you will not see all form items listed in the form specific completion instructions but rather only those items needing detailed explanation Below are additional instructions for some of the CRFs used in this study These instructions do not appear on the back of the form page due to lack of space Enrollment ENR CRF Randomization date and time Item 5 e The date and time of a participant s randomization should be completed using the FSTRF randomization confirmation email The randomization time within this confirmation email is provided in Eastern Standard Time EST When completing item 5 on the Enrollment CRF convert the time of randomization according to the site s local standard time zone MTN 028 SSP Manual Section 11 Version 1 1 Adverse Experience Log AE Do not wait until the AE resolves before faxing the form page to DF Net Always make changes corrections and updates to the originally completed form page do not complete a new form Once an AE Log form page has been started and faxed to DF Net Research the data from that page should never be transcribed onto another AE Log
16. ation Visits An early termination visit can occur at any point during the study after participant randomization If an early termination visit is conducted the Day 35 scheduled Final Clinic Visit procedures should be completed providing participant willingness The visit code of the early termination visit will depend on where the participant is at in her visit schedule at the time of early termination 11 3 3 Visit Codes and Page Numbers The MTN 028 non log CRFs will include boxes in the upper right corner for a visit code DataFax uses the visit code to identify the visit at which a CRF is completed When visit code boxes are MTN 028 SSP Manual Version 1 1 18 August 2015 Section 11 11 14 present site staff is responsible for recording the appropriate visit code The table below lists the visit codes assigned to each required follow up visit Table 11 2 Visit Code Assignments for Required Follow up Visits Visit SmMAAWAUMKRWY Visit Codes for Split Visits Visit Screening Visit Enrollment Visit Day 1 Day 2 Day 3 Day 7 Day 14 Day 21 Day 28 Day 29 Day 30 Day 31 Day 35 Final Clinic Visit Visit Code 01 0 02 0 03 0 04 0 05 0 06 0 07 0 08 0 09 0 10 0 11 0 12 0 13 0 See Section 11 3 2 for a definition of split visits When split visits occur the CRFs completed for the visit are all assigned the same visit code ending in 0 even though the dates will differ between some of the CRFs Visit Co
17. d to repeat screening attempts re screens by a participant If a participant re screens all screening procedures and CRFs must be repeated with the exception of PTID assignment and Eligibility Criteria CRF completion see paragraph below Once a PTID is assigned to a participant that PTID is used for the re screen procedures and forms completed for that participant do not assign a new PTID If a participant re screens and enrolls in the study only case report forms from the successful screening and enrollment visits are faxed to DF Net Note that in this case the Eligibility Criteria CRF completed during the failed screening attempt should be updated and re faxed with CRFs from the participant s successful screening and enrollment visits do not complete a new Eligibility Criteria CRF for the successful screening attempt Follow Up Visits For each required follow up study visit the visit type visit code target visit day and visit window are listed in Table 11 1 Target days and windows are listed in days with the day of enrollment randomization as study day 0 Target Days and Visit Windows Whenever possible visits should be completed on the target day or within the target window SCHARP will provide sites with a spreadsheet tool that may be used to generate individual participant follow up visit calendars based upon the participant s enrollment date and menstrual MTN 028 SSP Manual Version 1 1 18 August 2015 Section 11 11
18. des for Interim Visits For interim visits interim visit codes are assigned using the following guidelines e In the two boxes to the left of the decimal point record the two digit visit code for the most recently required visit even if the visit was missed and or if the participant is within the next visit s window e For the box to the right of the decimal point 1 the first interim visit after the most recently required follow up visit 2 the second interim visit after the most recently required follow up visit 3 the third interim visit after the most recently required follow up visit and so on Example 1 A participant completes her Day 31 visit visit code 12 0 on the target day She returns to the site one day later to report anew symptom This interim Visit is assigned an interim visit code of 12 1 MTN 028 SSP Manual Section 11 Version 1 1 18 August 2015 11 15 Visit code for this Interim Visit Visit Code 1 2 4 Page numbers Other CRFs such as log forms e g Adverse Experience Log or Concomitant Medications Log may include boxes in the upper right corner for page numbers as shown below roo CT Assign page numbers in sequential order starting with 01 or 001 for Adverse Experience Log CRFs Assign numbers in sequential order for example the second Concomitant Medications Log page would be assigned page number 02 the third page would be assigned 03 and so on 11
19. e correction as shown below yes no ty bal xX If the correct answer has previously been crossed out do the following e circle the correct item e write an explanation in the white space near the item and initial and date all corrections as shown below ENI yes no AA f ad N Ay Oo should be YES amp v The standards above must always be followed whenever a CRF is changed clarified or amended even if the change is made before the CRF is faxed to DF Net Research for the first time 11 2 7 How to Handle Missing and Unknown Data If the answer to an item is not known is not available or if the participant refuses to answer draw a single horizontal line through the blank boxes and initial and date the item It is helpful to write don t know refuses to answer UNK unknown N A not applicable or REF refused near the blank boxes For example when recording a date if the exact day is not known draw a single horizontal line through the dd boxes and write don t know next to the response boxes as shown below 9 re Se LAIP R OO sor A yy LN dd MMM A skip pattern is the only valid reason to leave a response blank Initials and date are required for any data item that is refused missing unknown or not applicable regardless of whether it is marked as such during the initial form completion or as an update to the form 11
20. e mail address kronos dfnetresearch com with instructions on logging into the Kronos system for the first time and setting up a new user password To obtain new user accounts for additional site staff members please contact the SCHARP Project Manager Once a site staff member logs into the Kronos site s he may access and download the iDataFax software by clicking on the DATAFAX 2014 project folder see screenshot below MTN 028 SSP Manual Version 1 1 18 August 2015 Section 11 11 3 dfnet a Home Home Welcome to Kronos Welcome to DF Net s LabKey web portal for the HVTN HPTN and MTN research networks To learn more about using LabKey please visit one of the community resources freely available on labkey org Documentation Tutorials Developer Guide Community Forums This server is maintained by DF Net Research s Data Analytics division If you need any help please contact us at kronos dfnetresearch com Projects The folder contains links for downloading the iDataFax software as well as an iDataFax User Manual with detailed instructions on downloading logging into and using iDataFax see screenshot below DataFax 2014 DataFax 2014 iDataFax 2014 Windows Installer iDataFax 2014 Windows Macintosh Installer iDataFax 2014 Macintosh References 18 August 2015 11 4 MTN 028 SSP Manual Version 1 1 Section 11 For technical assistance with logging into and navigating the Kronos
21. form page Note that AE Log page numbers do not need to be assigned in any special order with regard to AE onset date or date reported to site For example if it is discovered that for a participant page 001 and 003 were assigned but not 002 simply assign page 002 to the next AE Log form you complete It does not matter if the AE s onset date or date reported to site on page 002 is later than these dates reported on AE Log page 003 a QC will not be generated For item 1 note that planned procedures or surgeries are not AEs For example a tonsillectomy is not an AE rather it is a treatment that will be collected in item 8 Any adverse experiences associated with the planned procedure or surgery are AEs Provide a rationale or alternative etiology in the Comments section for all reported AE regardless of relationship to study product Ensure that any relevant information provided in the Comments section is also provided in item 1 the text description of the AE This will help avoid MedDRA coding queries during the study For example if a participant reports vaginal discharge and the AE is deemed not related to study product due to an infectious etiology provide relevant descriptors either the diagnosis or that the vaginal discharge is due to infection in item 1 Pharmacokinetics Specimens Enrollment PKS 1 In item 1 record the start and stop dates of the participant s last last menstrual period If the participant is unable
22. herence Ring Collection and Insertion Specimen Storage Safety Laboratory Results Visit Days 29 30 amp 31 Visit Code 10 0 12 0 DataFax forms Non DataFax forms MTN 028 SSP Manual Version 1 1 Section 11 18 August 2015 11 17 Follow up Visit Summary Pelvic Exam Physical Exam 14 21 29 30 31 35 Pharmacokinetics Specimens Days 1 2 3 7 Pelvic Exam Diagrams Visit Day 35 Visit Code 13 0 DataFax forms Non DataFax forms Follow up Visit Summary HIV Results Pelvic Exam Physical Exam 21 29 30 31 35 Safety Laboratory Results Specimen Storage Termination Pharmacokinetics Specimens Days 1 2 3 7 14 Pelvic Exam Diagrams 11 3 7 Completing Interviewer administered Forms In order to standardize interviewer administered data collection from site to site and to maximize quality it is critical that participant interviews be conducted with a non biased non judgmental approach Study staff should help a participant feel comfortable sharing personal information and opinions while asking the study questions in a consistent manner from participant to participant 11 3 8 Site Review Quality Control of DataFax Forms As described in the site s MTN Data Management SOP and referenced in the site s Clinical Quality Management Plan CQMP each site must perform two Quality Control QC review steps prior to faxing DataFax forms to DF Net Research While D
23. item unless instructed otherwise by a skip pattern Never obscure mark over or punch holes through the barcode at the top of each CRF DataFax requires the barcode to identify the CRF Never use correction fluid white out or correction tape on CRFs Remove any paper clips staples or other attachments before faxing CRFs The site staff person who initially completes the form must record his her initials and the date in the space provided in the bottom right hand corner of each CRF page Fax forms as soon as possible after they have been completed and reviewed Ideally completed forms will be faxed to DF Net within 1 2 days of completing the visit though up to 5 days is allowed MTN 028 SSP Manual Version 1 1 18 August 2015 Section 11 11 5 11 2 2 How to Mark Response Boxes Many items on DataFax CRFs have a box or series of boxes for recording a response Mark the box clearly with an X Do not fill in the box with shading or mark it with a slash or other character Correct Incorrect Mark only one response box for each item unless the Mark all that apply instruction is present 11 2 3 How to Record Numbers Some questions on DataFax CRFs include boxes for recording a numeric response DataFax can only read the numbers in these boxes if they are recorded clearly The following instructions should be followed when recording numeric responses e Right justify all numbers and fill in any blank leading boxes
24. lvic Exam Ring Assessment PER e When completing the PER CRF at the Day 28 visit mark yes in item 2 if the vaginal ring was present at the start of the exam as you will remove and collect the vaginal ring at this visit The hour and minute boxes in item 2a should be lined through initialed and dated to indicate that this item is not applicable Item 3 should be marked not reinserted For item 3a record Day 28 end of product use as the reason that the ring was not reinserted 11 5 Case Report Forms The MTN 028 CRFs are posted on the ATLAS webpage for downloading and printing The current version of the MTN 028 case report forms not for actual data collection purposes use can be found on the MTN 028 SSP web page on the MTN website www mtnstopshiv org MTN 028 SSP Manual Version 1 1 18 August 2015 Section 11 11 20
25. ntion SCHARP is located in Seattle USA and is in the US Pacific Time PT time zone The DataFax database will be housed at DF Net Research The SCHARP MTN 028 team members along with their job role and e mail address are listed below MTN 028 SSP Manual Version 1 1 18 August 2015 Section 11 11 1 MTN 028 Statistical and Data Management Center SDMC Staff Job Role Name Email Address Protocol Statistician Jingyang Zhang Jzhang2 fhcre org Statistical Research Associate Jason Pan zpan fhcrc org Project Manager Melissa Peda mapeda scharp org Operations Programmer Drew Edwards drew scharp org Database Manager Dena Seabrook dena dfnetresearch com Lab Programmer Katie Snapinn ksnapinn scharp org Clinical Affairs Safety Associate Ning Jiang njiang2 scharp org 11 1 DataFax Overview DataFax is the data management system used by DF Net Research to receive and manage data collected at study sites The site faxes an electronic image of each case report form CRF to DataFax and the original hard copy CRF is retained by the site 11 1 1 CRF Transmission and Troubleshooting Case report forms can be transmitted to DF Net Research in one of two ways faxed using a fax machine connected to a land phone line fax to phone number 1 866 807 8681 or faxed using a fax machine connected to the internet fax to e mail lt mtn dfnetresearch com gt DF Net Research s DataFax support group is available to c
26. onsult with the site to determine the best method for data transmission The DataFax support group can be contacted via e mail at lt support datafax com gt This group should also be contacted anytime the site has technical questions or problems with their fax equipment MTN 028 SSP Manual Version 1 1 18 August 2015 Section 11 11 2 11 1 2 Data Entry Quality Control Once a CRF image is received by DF Net the following occurs e DataFax identifies the study to which each CRF belongs using the barcode at the top of the form It reads and enters the data into the study database and stores each CRF on a computer disk e Next each CRF is reviewed by at least two staff members at DF Net Problems such as missing or potentially incorrect data are identified and marked with Quality Control notes QCs QCs are compiled into QC reports that are sent via e mail to the study site on a regular basis Sites are asked to correct or clarify any problems identified on the QC reports and refax the corrected CRFs to DF Net e When the refaxed pages are received DF Net Research staff review the corrected pages and resolve the QCs If a change is made to a CRF but the updated page is not refaxed to DF Net Research DataFax the change will not be entered and the study database will continue to contain incomplete or incorrect data Additionally if the change was prompted by a QC the QC will continue to appear on subsequent QC reports until the modified CR
27. pant screened for the study The PTIDs are assigned in sequential order as participants present for the screening visit The site should ensure that each PTID is assigned only once Once a participant has received a PTID that same PTID is maintained for that participant for the duration of her study participation MTN 028 SSP Manual Version 1 1 18 August 2015 Section 11 11 11 PTID boxes are located near the upper left corner of each CRF page The PTIDs used for this study are nine digits and formatted as XXX YYYYY Z The PTID consists of three parts the DataFax site number XXX the participant number YYYYY and a numerical check digit Z The check digit Z is a number generated by SCHARP with the participant number and helps ensure that the correct PTID is recorded Below is an example of the PTID structure used in MTN 028 Participant ID Site Number Participant Number Chk 11 3 2 Study Visit Timing Screening and Enrollment The initial screening visit is defined as the day the participant provided written informed consent to be screened and enrolled for the study The initial Screening Visit that is the date the informed consent form was signed for screening and enrollment may take place up to 45 days prior to the Enrollment Visit The date the participant is enrolled randomized is Study Day 0 for the participant Screening Attempts Re screens Refer to Section 4 Study Procedures of this manual for guidance relate
28. s wvaire eecbon os Geico eieartieas coset nc nto ccpa tee Gloee 11 11 11 3 1 Participant ID numbers PTIDs sss ence toepst Sgeeeetiaie cocci emma aceon 11 11 11 3 2 SAV MIST eT LID 2 cccraee ecg opitene ieee ee a ee eed E A a ae 11 12 11 3 3 Visit Codes and Page Numbers lt 5 a4 ssetncerceeteandoeeatetaiac reed Rewer 11 14 11 3 4 PCAN IRN SEY MG acc a reco ee rev E S OAE R 11 16 11 3 5 FOM SUSY Sc cet ase lett a told rd cat tas wes a toet pec rah E 11 16 11 3 6 Case Report Form Completion Schedule cccccsscsccsssescsessecsesseseesseeecsesecaeseesaesaeseeeaees 11 16 11 3 7 Completing Interviewer administered FOrMs ccccccesssecssscessecseseecsneeesseessssecseseeeees 11 18 11 3 8 Site Review Quality Control of DataFax FOrMS ccccsccesssscesseceeseecsseeeesneessseeeeseeecees 11 18 11 4 Form specific Completion Instructions cccccsessccececesesseseeaeceeeceseeseaeseceeecsseeseaeaeeeesesseeseaaeas 11 18 11 5 Case Report ROMS saani u E E E EE T EET E ER EEE RT T 11 20 The purpose of this document is to provide site staff with the information they need to successfully complete and submit MTN 028 case report forms For questions about this section or about general data collection policies procedures or materials please contact the SCHARP Project Manager for the study as listed below The SDMC Statistical and Data Management Center for this study is SCHARP the Statistical Center for HIV AIDS Research and Preve
29. t has already been completed An interim visit may also occur via a phone contact if the participant reports a new AE that requires reporting on an AE 1 CRF or the participant is instructed by study staff to hold or permanently discontinue study product use All interim contacts with the participant should be documented in a chart note Additionally if the interim contact results in at least one newly completed DataFax CRF the interim contact is assigned an interim visit code visit code ending in something other than 0 All phone contacts that meet interim visit criteria per paragraph above are also assigned interim visit codes See section 11 3 3 for information on how to assign visit codes to interim visits Note that for MTN 028 there is no Interim Visit CRF Instead a Follow up Visit Summary CRF is completed for interim visits contacts as needed Item 6 of the Follow up Visit Summary CRF will document whether the visit is a required regular visit or an interim visit The following is an example of an interim visits A participant completes her Day 7 visit as scheduled On Day 10 post enrollment the participant reports to the clinic unexpectedly to report a new AE Why is this an interim visit The required visit procedures for the Day 7 visit have been completed already and a new AE is reported An interim visit code is assigned as new CRFs will be completed Follow up Visit Summary AE Log possibly others Early Termin
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