IMPAACT 2010 Data Management Center Ben Johnston and Chelsea Krotje - - PowerPoint PPT Presentation

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
• n 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

Exclusion Criteria

• The same rules apply for the section regarding Exclusion Criteria and the final Additional Reasons

section:

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 – Delivery – Postpartum – Confirmation of Virologic Failure

Folders

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

Example: P1115 questionnaires

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

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

• Log-style forms:

– CMW10001: Concomitant Medications Log – DXW10001: Targeted Pregnancy Diagnoses – EVW10013: Pregnancy Outcome Log – LBW10009: Laboratory Test Results (Chem/Hem)

There are two main types of forms: Log and Portrait.

Log lines can be added as needed for multiple lines

• f data

– LGW10000: Informed Consent Status Log – MHW10001: Medical History Log – Many others…

Portrait Style

• 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…

There are two main types of forms: Log and Portrait.

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)

CMW10001: Concomitant Medications Log

• Be sure to read all 2010-specific instructions (Protocol Sections 5.8, 6.11, and 6.14)

– ALL infant ARVs are recorded here – Maternal ARVs taken prior to pregnancy AND prior to entry are recorded here – Maternal ARVs other than study drug are also recorded here

• Updated when medications are stopped, started, or modified

– Add log lines as needed for each reportable medication

Reporting Study Drug(s)

• All study-defined drug(s) are to be reported on the TXW10001: Treatment Log

– Study drugs defined in protocol Section 5 (DTG. FTC/TAF, FTC/TDF, EFV/FTC/TDF) are reported on this form

– Any OTHER medications (those not defined in the protocol as study drug) are to be reported on the CMW10001: Concomitant Medications Log, whether or not they are ARVs

Study Event Tracking (Maternal)

SVW10001: Study Event Tracking (Maternal)

• Any time an Adverse Event is

required to be reported per the protocol, fill out this question as “Yes”

– Refer to Protocol Section7.2 for reporting requirements

• Example: Upon clicking “Save,” a

sticky note will appear guiding the site to complete/update the ADE10002: Adverse Event Log

Study Event Tracking (Maternal)

SVW10001: Study Event Tracking (Maternal)

ADE10002: Adverse Event Log

• ADE10002: Adverse Event Log essentially replaces the legacy Diagnoses,

Signs/Symptoms, and Event Evaluation forms

• Each event has its own log line

– Primary events, S/S, associated events, etc. each have their own line

• Running log of all adverse events for the particular participant

– Log lines can be added as needed

ADE10002: Adverse Event Log

Complete View Portrait View

“Participant-level” Forms

• Any eCRF at the “participant level” can be updated at any point

during the study

• Only one copy of the form exists throughout the study
• These forms appear in their own Participant Level folder
• Includes data such as adverse events, concomitant medications,

informed consents, pregnancy outcomes, etc.

• Sites will also be directed to complete/update these according to

the schedule of evaluations

REQUIRED FORMS

Completion of Required Forms

• Required forms are pre-loaded into folders at each study visit

– Loaded once the initial appropriate Study Event Tracking form is successfully saved

• Examples include:

– Participant questionnaires – Laboratory test results – Pharmacokinetic specimens – Vital signs

Required Forms - VSW10000: Vital Signs

• The VSW10000: Vital Signs

is the maternal vital signs form that is required at most study visits

– Refer to Protocol Section 6.12 for maternal examination requirements

• Collects:

– Height (at screening only) – Weight – Blood Pressure

Oops…

• Let’s pretend that Vital Signs were not collected. A site answered the leading question
• n this form as “No,” then clicked “Save” before entering data into any other fields.
• A query was generated:

Query Reconciliation

• The query fired because a reason was not provided for why vital signs were not collected

By clicking the pencil icon, the site can view the query and respond directly while updating the data

Queries in Rave

• You will have received training on query management in

the Overview Rave eLearnings

• For more information on managing queries, see the “Daily

QA in Rave” presentation

Required Forms: Participant Questionnaires

• Participant Questionnaires:

– QLW10000: Edinburgh Postnatal Depression Scale – QLW10001: Routine Adherence Assessment – QLW10004: Barriers to Adherence – QLW10007: Facilitators of Adherence – QLW10005: Pittsburgh Sleep Quality Index (PSQI) – QLW10006: Generalized Anxiety Disorder 7-item (GAD-7) Scale

• These will also be available on the Forms Management Utility for download
• Let’s take a look at some in detail…

QLW10001: Routine Adherence Assessment

• Routine Adherence

Assessment completed for the mother at nearly every study visit

• Broken down into four

items related to adherence to study drug

• ver the last 30 days
• The last question is a

Visual Analog Scale

• n which the participant

can point to the line that best represents their self-reported adherence level

QLW10001: Routine Adherence Assessment

If, for any reason, the questionnaire was not completed when required, provide the reason at the top of the screen before Saving

Barriers to and Facilitators of Adherence

• Because of Rave functionality, these are separated into two

forms:

– QLW10004: Barriers to Adherence – QLW10007: Facilitators of Adherence

QLW10004: Barriers to Adherence

• QLW10004: Barriers of

Adherence is required at the maternal visits Antepartum Week 8 and Postpartum Week 38

• Depending on the Visit Week,

different instructions may apply (Week 8 vs Week 38)

• First indicate whether or not the

questionnaire was completed (provide reason if not)

• The interviewer will read each

barrier item to the participant, then check “Yes”, “No”, or “Declined to answer”

QLW10004: Barriers to Adherence

• If there are any barriers to adherence noted by the participant that are

not listed, select “Other barrier” from the drop down menu and provide text in the corresponding field

QLW10007: Facilitators of Adherence

• The same rules apply

when filling out the Facilitators of Adherence eCRF

• Mark a check box if

“Yes,” or leave blank if “No” or if the participant declined to answer

Targeted Pregnancy Diagnoses

• DXW10001: Targeted

Pregnancy Diagnoses is required at 2 different study visits (possibly 3)

– Entry – Delivery – Possibly at Postpartum Week 50 (if subsequent pregnancy occurs on- study)

When any diagnosis is checked, indicate # of completed gestational weeks at time of diagnosis

Targeted Pregnancy Diagnoses

• At Entry, record any

complications during the current pregnancy up to the time of enrollment

• At the Delivery Visit,

record any complications that occurred after enrollment and up to 14 days postpartum that were not previously reported at Entry

Delivery Visit

• A few of the required forms at the Delivery Visit include (but are not limited to):

MATERNAL FORMS INFANT FORMS

• DXW10001: Targeted Pregnancy

Diagnoses

• EVW10013: Pregnancy Outcome Log
• EVW10015: Labor Record
• EVW10018: Delivery Record
• DXW10000: Congenital Anomalies
• EVW10016: Newborn Exam
• QLW10010: Infant Feeding Method
• QLW10011: Breastfeeding, Formula, and

Complementary Food Record

• VSW10001: Vital Signs - Infant

Maternal Forms – Delivery Visit

• The Delivery visit folder contains all required forms for that visit
• SVW10001: Study Event Tracking (Maternal) prompts the site to fill out logs that

are located at the Participant Level

– For example, the EVW10013: Pregnancy Outcome Log will need to be updated once the site marks “Yes,” indicating that there has been a pregnancy outcome that needs to be reported

• DXW10001: Targeted Pregnancy Diagnoses
• EVW10013: Pregnancy Outcome Log
• EVW10015: Labor Record
• EVW10018: Delivery Record

Maternal Forms – EVW10013: Pregnancy Outcome Log

• Filled out under the mother’s PID
• Within the eCRF, indicate the corresponding infant PID
• Provide the outcome and the corresponding date, along with a narrative of the

circumstances

• IF the outcome is indicated as Stillbirth, then the two fields related to stillbirth diagnosis

and macerated skin changes are required to be completed

Delivery Visit

MATERNAL FORMS

• DXW10001: Targeted Pregnancy Diagnoses
• EVW10013: Pregnancy Outcome Log
• EVW10015: Labor Record
• EVW10018: Delivery Record

Maternal Forms – EVW10015: Labor Record

• Included in the Delivery visit

folder

• Collects information on:

– If mother was in labor prior to delivery – Membrane rupture – Spontaneous vs. induced labor – Adverse events experienced during labor – Concomitant medications during labor – Corticosteroids for preterm labor at any point during the pregnancy

Maternal Forms – EVW10015: Labor Record

Sticky notes will also appear as a prompt and must be acknowledged If labor was induced, provide a reason for indication Help text prompts site to fill out CMW10001: Concomitant Medications Log Help text prompts site to fill out ADE10002: Adverse Events Log

Delivery Visit

MATERNAL FORMS

• DXW10001: Targeted Pregnancy Diagnoses
• EVW10013: Pregnancy Outcome Log
• EVW10015: Labor Record
• EVW10018: Delivery Record

Maternal Forms – EVW10018: Delivery Record

• The Delivery Record is completed under the mother’s PID
• Provides information on the date, time, and type of delivery
• Be sure to enter the corresponding Infant PID in the first column of the log
• Each log line corresponds to one infant
• Log lines can be added as needed

If it was indicated that the 6. Type of Delivery was cesarean section, then you must provide the primary indication for the cesarean in the drop down of 6a.

Infant Forms

• Infants are enrolled in

utero and randomized in pairs with their mothers

• Once the infant is born

(or other pregnancy

• utcome occurs), you

will then complete forms for the infant, starting with the Delivery visit

Delivery Visit

• A few of the required forms at the Delivery Visit include (but are not limited to):

MATERNAL FORMS INFANT FORMS

• DXW10001: Targeted Pregnancy

Diagnoses

• EVW10013: Pregnancy Outcome Log
• EVW10015: Labor Record
• EVW10018: Delivery Record
• DXW10000: Congenital Anomalies
• EVW10016: Newborn Exam
• QLW10010: Infant Feeding Method
• QLW10011: Breastfeeding, Formula, and

Complementary Food Record

• VSW10001: Vital Signs - Infant

Delivery Visit

INFANT FORMS

• DXW10000: Congenital Anomalies
• EVW10016: Newborn Exam
• QLW10010: Infant Feeding Method
• QLW10011: Breastfeeding, Formula, and

Complementary Food Record

• VSW10001: Vital Signs - Infant

Infant Forms – EVW10016: Newborn Exam

• Data elements recorded here

include:

– Date of exam – General activity – Physical exam – Apgar scores – Anthropometric measurements

Infant Forms – EVW10016: Newborn Exam

• Complete the Newborn Exam

with information taken immediately after birth

• This is separate from the

regularly-scheduled examinations to be taken at the Delivery Visit itself

– Information extracted from the Delivery Visit itself is not recorded on this form

Delivery Visit

INFANT FORMS

• DXW10000: Congenital Anomalies
• EVW10016: Newborn Exam
• QLW10010: Infant Feeding Method
• QLW10011: Breastfeeding, Formula, and

Complementary Food Record

• VSW10001: Vital Signs - Infant

Infant Forms – QLW10010: Infant Feeding Method

• Complete this eCRF at the Delivery Visit and every subsequent visit to record

feeding information

• This form works hand-in-hand with the QLW10011: Breastfeeding, Formula, and

Complementary Food Record

• Upon completion, a prompt appears to navigate to the QLW10011: Breastfeeding,

Formula, and Complementary Food Record; complete the proper section accordingly

Within the form, indicate any feeding method that has been used since the last visit, and check all that apply

Infant Forms – QLW10011: Breastfeeding, Formula, and Complementary Food Record

• When prompted by the

QLW10010, fill out ONLY the appropriate section

I. NEVER BREASTFED

Completed only if it’s been determined that the infant will never breastfeed

II. INITIAL BREASTFEEDING EXPOSURE

Completed only if the infant has ever been breastfed

• III. BREASTFEEDING DISCONTINUATION

(WEANING)

Completed only if the infant has been completely weaned from breastmilk

• IV. INITIATION OF FORMULA

Completed only when formula is first introduced

• V. INITIATION OF COMPLEMENTARY FOOD

Completed only when complementary food is first introduced

Infant Forms – QLW10011: Breastfeeding, Formula, and Complementary Food Record

• QLW10011 exists at the Participant Level, meaning it can

be updated and modified at any time during the study

• If an infant is weaned, but then subsequently suckles

again, the weaning information would need to be updated

Study Event Tracking (Infant)

SVW10000: Study Event Tracking (Infant)

• Besides the required evaluations, data

completion for other infant forms is also event-directed

• As with SVW10001 (Maternal), when any

question is answered “Yes,” upon clicking “Save,” a sticky note appears to guide the site to complete the corresponding eCRF

– Consent Status – Adverse Event Log – Concomitant Medications Log – Congenital Anomalies

Delivery Visit

INFANT FORMS

• DXW10000: Congenital Anomalies
• EVW10016: Newborn Exam
• QLW10010: Infant Feeding Method
• QLW10011: Breastfeeding, Formula, and

Complementary Food Record

• VSW10001: Vital Signs - Infant

Infant Forms – DXW10000: Congenital Anomalies

• When the question on the SVW10000: Study Event Tracking (Infant) is answered “Yes,”

a prompt appears indicating that the Congenital Anomalies form must be completed

• HOWEVER, be sure to first complete the ADE10002: Adverse Events Log under the

infant’s PID so that the proper AE term is populated within the Congenital Anomalies eCRF

Infant Forms – DXW10000: Congenital Anomalies

• After selecting the congenital anomaly term, provide a detailed narrative in the space

provided

• Character limits are set at 200 for the narrative field, but log lines can be added as

needed to provide more space for free text

• Enter the date the anomaly was first identified
• Per the protocol, photographs of the anomalies should also be submitted

File Exchange Utility

• Protocol Section 6.16 refers to the upload of congenital anomaly photographs for Clinical

Monitoring Committee Review

• All uploading of photographs is done through the File Exchange Utility located on the Frontier

Science Portal (http://www.frontierscience.org/)

• ALL PHOTOS MUST BE PROPERLY REDACTED
• A reference guide is available to Portal users that explains the mechanics of uploading

QUESTIONS?

If you have questions during the study:

• eCRFs, Schedules, etc.:

– Ben Johnston : johnston@fstrf.org – Chelsea Krotje : krotje@fstrf.org

• Enrollment and Randomization Questions:

– rando.support@fstrf.org

• Technical Issues:

– user.support@fstrf.org

• Protocol and Patient Management:

– impaact.team2010@fstrf.org