Study on Safety of Long-Acting Injectable Treatment in Virologically Suppressed HIV-Infected Children
Explore the IMPAACT 2017 Phase I/II study focusing on the safety, acceptability, and tolerability of long-acting injectable cabotegravir and rilpivirine in HIV-infected children and adolescents. The webinar covers study-specific eCRF considerations, data management, drug accountability, and more. Join the session for valuable insights.
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Presentation Transcript
IMPAACT 2017 Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV- Infected Children and Adolescents MOCHA More Options for Children and Adolescents
Welcome to the webinar! The session will begin shortly. Please mute your phone line (*6) to improve sound quality during the session. Do not place your phone line on hold during the session. Reminder: Document this training!
MOCHA STUDY-SPECIFIC eCRF CONSIDERATIONS 13 July 2022 Barbara Heckman, Jared Kneebone, Andi Ace Data Managers
Agenda eCRF Refreshers from V3.0 and Updates for V4.0 Requesting Data Updates Following a Database Freeze IMPAACT 2017 Resources and Communications Questions?
ECRF REFRESHERS FROM V3.0 AND UPDATES FOR V4.0
LBW10002: Chemistry/Hematology Test Results Log Common scenario: upper and lower limits of normal not available for creatinine clearance results Resolution: respond to resulting Site from System queries and PDMs will acknowledge and close
DGW10019: IMPAACT 2017 Abbreviated Electrocardiogram (ECG) Results Log
DGW10019: IMPAACT 2017 Abbreviated Electrocardiogram (ECG) Results Log
EVW10031: IMPAACT 2017 Drug Accountability Log When pills are returned do not return them to the pharmacy, send them home with the participant If the pill count indicates a level of non adherence, please issue a DM from Site query Date dispensed is the date the pills were originally dispensed
Participant Logs Found in the Participant folder Any eCRF at the participant level can be updated at any point during the study Includes data such as oral treatment info, informed consents, concomitant medications, etc. Sites will also be directed to complete/update these according to the schedule of evaluations and answers on the Study Event Tracking forms. Examples of Participant Logs ADE 10003: Adverse Events Log (Multi) ADM10008: Discontinuation Log CMW10000: Concomitant Medications Log LGW10004: Informed Consent Status Log MHW10000: Medical History Log TXW10004: IMPAACT 2017 Oral Study Treatment Log
ADM10008: Discontinuation Log Discontinuation Week should be counted from the date of the participant s initial enrollment to the study (see updated form instructions) For Study Step discontinuations, Discontinuation Date should equal the date of the subsequent step enrollment
ADE10003: Adverse Events Log (Multi) All adverse events reported on this form, including injection site reactions For abnormal laboratory events, questions 6 8 should be left blank For all events on the form, grading is expected (Grade 8 Not Gradable is not applicable) If Adverse Event is due to injection site reaction use left or right buttock in the description of the term. When reporting study treatment, indicate if the treatment is either an oral or an injectable medication.
CMW10000: Concomitant Medications Log Be sure to read all instructions New log lines can be added as needed When logging discontinuation of cART for new Step 3 enrollees, Study-defined Design should be selected as the Reason for Modification A complete ARV history is required to be documented
REQUESTING DATA UPDATES FOLLOWING A DATABASE FREEZE
Requests to Unfreeze Data Sites are required to take the following steps if data that has previously been frozen requires modification: 1. Open a DM From Site query on the appropriate field in Rave ** this query should explicitly specify what the data are being updated to** 2. The DMC will obtain the necessary internal approvals and, once approved, the data will be unfrozen 3. The DMC will respond to the DM From Site query notifying the site that the data can be updated 4. Once the data are updated, the site should close out their DM From Site query
Medidata Rave Resources Found on the Frontier Science Portal Website (www.frontierscience.org)
If you have questions during the study: eCRFs, Schedules, etc.: Barb Heckman: bheckman@frontierscience.org Jared Kneebone: kneebone@frontierscience.org Andi Ace: ace@frontierscience.org Enrollment and Randomization Questions: rando.support@fstrf.org Technical Issues: user.support@fstrf.org Protocol and Patient Management: impaact.2017CMC@fstrf.org impaact.team2017@fstrf.org
