IMPAACT 2010 Data Management Center Ben Johnston and Chelsea Krotje Protocol Data Managers August 2017
Agenda • Eligibility Checklist • Screening Failures and Non-Enrollments • Schedules • eCRFs • Resources • Questions?
SUBJECT ENROLLMENT SYSTEM & ELIGIBILITY CHECKLIST
Subject Enrollment System • Sites will continue to utilize the Subject Enrollment System (available on the Frontier Science Portal at http://www.frontierscience.org/) for all enrollments into Rave studies – This process remains unchanged
Subject Enrollment System • Screening numbers are obtained for every potential mother- infant pair • Only one number is assigned per pair – Multiple screening attempts are allowed in 2010. In this case, a new screening number would be assigned if a second attempt is made • All screening numbers must be resolved in one of two ways: – Successful enrollment in IMPAACT 2010 – Completion of SCR10001: IMPAACT 2010 Screening Failure and Non-Enrollment Results eCRF
Eligibility Checklist
Successful Enrollment • Enrollments subsequently appear in Medidata Rave shortly after using the SES – At time of enrollment, visits and data collection screens will be available
SCREENING FAILURES & NON-ENROLLMENTS
Screening Failure • Sites must complete the SCR10001: IMPAACT 2010 Screening Failure and Non-Enrollment Results eCRF as soon as possible after identifying any failures or non- enrollments
SCR10001: IMPAACT 2010 Screening Failure Inclusion Criteria • When filling out the SCR10001, indicate which particular criteria were passed or failed (if applicable) • IF the participant did not fail any inclusion criteria, the site can answer the first leading question as “No” – If so, then all the Inclusion Criteria questions do not need to be filled out – Specific fields related to Inclusion Criteria are not required to be filled out unless the answer to the leading question is “Yes”; then each field is required in this section
Exclusion Criteria • The same rules apply for the section regarding Exclusion Criteria and the final Additional Reasons section: Exclusion Criteria Leading question: • Answered “ No ,” no other fields are to be completed • Answered “ Yes ,” each field in the section required to be completed Additional Reasons
SCHEDULES
Schedules of Evaluation • The required forms for each visit are in Rave • Visit folders contain all required eCRFs to be completed for the given visit • The Data Collection Forms Schedules will be at the beginning of the eCRF Completion Guide (to be discussed)
Visit Folders • Visit Folders correspond to the scheduled visits in the protocol • Structure remains unchanged • Some examples of visit folders for IMPAACT 2010 include: – Screening – Entry – Antepartum Folders – Delivery – Postpartum – Confirmation of Virologic Failure
Unscheduled Visits • For any unscheduled visit, sites can “Add Event” from the main page in Rave – This allows certain forms to be added for the unscheduled data collections • This is to be done only when there is an unscheduled visit, or when additional data are needed to be entered that are not otherwise already loaded into the given Visit Folder
FORMS
Rave • IMPAACT 2010 utilizes Medidata Rave, an electronic data capture system • As the name implies, all data for this study will be entered electronically into eCRFs – “Form” = “CRF” = “eCRF” = “Screen”
List of Forms • Study-specific questionnaires will also be made available for download and translation to local language on the Forms Management Utility on the Frontier Science Portal • Each eCRF has a corresponding OID (three letters followed by number) – i.e. ADM10000, LBW10010, PKW10003, etc.
Translation into Local Languages • Study-specific questionnaires will be on the Forms Management Utility for translation into local languages • For further details regarding procedures for translation, see the IMPAACT Manual of Procedures (http://www.impaactnetwork.org/resources/policies-procedures.htm) • Site staff work with the study team and Protocol Data Manager through the process
Translation into Local Languages • Email address: CRFtranslations@fstrf.org • The PDM will send the site a Word Document copy of the questionnaire(s) to be translated once we have protocol team sign-off • Site translates and back-translates into local language • Then, send back to the DMC for review and approval – The PDM facilitates any back-and-forth communication needed to correct the documents Example: P1115 questionnaires
Help Text • Help Text is information that appears next to certain data fields that provide further guidance on how to complete the particular field – Appears as a “?” on the Rave screen • Click the Question Mark box next to any field to display the help text associated with it
eCRF Completion Guide • A complete packet of eCRFs called the eCRF Completion Guide will be made available to sites on the Frontier Science Portal – Displays all protocol-specific notes associated with each form – All help text is displayed directly • Helpful in determining how to fill out certain eCRFs • Examples:
eCRF Completion Guide – Specimen Tracking Log • SPW10001: Specimen Tracking Log is displayed differently from other eCRFs for ease of use – One for mother, one for infant • Better mimics how the form appears in Rave
Log Style There are two main types of forms: Log and Portrait . • Log-style forms: – CMW10001: Concomitant Medications Log – LGW10000: Informed Consent Status Log – DXW10001: Targeted Pregnancy Diagnoses – MHW10001: Medical History Log – EVW10013: Pregnancy Outcome Log – Many others… – LBW10009: Laboratory Test Results (Chem/Hem) Log lines can be added as needed for multiple lines of data
Portrait Style There are two main types of forms: Log and Portrait . • Portrait-style forms: – ADM10011: Visit Tracking – HXW10004: Alcohol and Tobacco Use – QLW10000: Edinburgh Postnatal Depression Scale – QLW10001: Routine Adherence Assessment – SVW10001: Study Event Tracking (Maternal) – SVW10000: Study Event Tracking (Infant) – Many others…
Mixed Style • Some forms are a mix of log and portrait… – EVW10012: Ultrasound – QLW10004: Barriers to Adherence – QLW10007: Facilitators of Adherence Portrait questions Log questions
DATA COLLECTION IN IMPAACT 2010
Visit Tracking eCRFs • For 2010, data collection will largely be completed in an event-directed fashion – ADM10011: Visit Tracking – SVW10001: Study Event Tracking (Maternal) – SVW10000: Study Event Tracking (Infant) • These eCRFs direct the completion of other eCRFs • Complete these forms FIRST , and then other forms roll out
Visit Tracking ADM10011: Visit Tracking • At each required visit, sites first fill out ADM10011: Visit Tracking, indicating the following: – The date of the visit/contact – Whether or not the visit occurred – Reasons for missed visit (if applicable) • Upon clicking “Save,” appropriate Visit Folder is loaded for the visit – All required forms are pre-loaded into Matrices after completion of Study Event Tracking • Site is then directed to the Study Event Tracking eCRF for further completion
Event-directed eCRFs • The Study Event Tracking form directs completion of other eCRFs: – Reportable laboratory test results – Reportable adverse events – New or updated medication information – Medical history information – And much more… • Upon saving the Study Event Tracking form, the pre-loaded required forms for that visit appear
Study Event Tracking eCRFs SVW10001: Study Event Tracking (Maternal) • At the beginning of the study, this maternal eCRF is completed and directs the completion of other potential data to be collected • All questions are required to be answered before clicking “Save” – A query will be generated if a required field is not filled in • Example: If this question is answered . “Yes,” upon clicking “Save,” a sticky note appears to guide the site to complete/update the corresponding MHW10001: Medical History Log
Study Event Tracking eCRFs SVW10001: Study Event Tracking (Maternal) ….upon clicking “Save,” a sticky note appears to guide the site to complete/update the corresponding MHW10001: Medical History Log .
MHW10001: Medical History Log • MHW10001: Medical History Log – Be sure to read the protocol (sections 6.11, 6.12, and 7.2) and all 2010-specific instructions – Add log lines as needed for each reportable pre-existing condition • Sites can come back into this form and update any conditions that resolve after entry
Study Event Tracking (Maternal) SVW10001: Study Event Tracking (Maternal) • When this question is answered “Yes,” upon clicking “Save,” a sticky note will appear guiding the site to complete/update the corresponding CMW10001: Concomitant Medications Log
Study Event Tracking (Maternal) SVW10001: Study Event Tracking (Maternal)
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