Accurate and Complete Data Acquisition for Clinical TrialsNCT05020951
Pilot Study to Enable Electronic Laboratory Data Transfer From Participating Institutions to MediData/RAVE
An observational study of Accurate and Complete Data Acquisition for Clinical Trials, run by Children's Oncology Group at 8 sites in United States.
Trial summary
An initial step toward more accurate and complete data acquisition for clinical trials, the Pediatric Early Phase Clinical Trials Network (PEP-CTN) and Pediatric Brain Tumor Consortium (PBTC) will assess the feasibility of electronic transfer of laboratory data from participating institutions' local electronic health… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Accurate and Complete Data Acquisition for Clinical Trials
- What is being tested?
- Medidata RAVE
- How many people
- 46 participants
- Where
- 8 sitesUnited States
- Study dates
- 28 Aug 2021to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Laboratory data from patients previously enrolled on selected PEP-CTN and PBTC trials. Studies include ADVL1412, ADVL1312, ADVL1411, PBTC-042, PBTC-047 (Stratum 1), PBTC-050, and PBTC-051.
Who may be able to join
- Patient Data Inclusion Criteria: Specific patient clinical research data to be included in this study for retrospective data capture and analysis will originate from the following PEP-CTN and PBTC studies:
- PEP-CTN: ADVL1412, ADVL1312, ADVL1411
- PBTC: PBTC-042, PBTC-047 (Stratum 1), PBTC-050, PBTC-051 (Stratum 1)
- Participating Site Inclusion Criteria: Data from above clinical studies at the following institutions will be included in the initial pilot, with potential to expand to other sites at which patients on these studies were treated.
- Site Participation: Children's Healthcare of Atlanta - Scottish Rite and Egleston, Children's Hospital of Philadelphia, Memorial Sloan Kettering Cancer Center, Seattle Children's Hospital, St. Jude Children's Research Hospital, Texas Children's Hospital, and University of California, San Francisco - Mission Bay
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, 30322
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Texas Children's Hospital
Houston, Texas, 77030
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
UCSF Medical Center-Mission Bay
San Francisco, California, 94158
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: Pilot Study to Enable Electronic Laboratory Data Transfer Into Medidata Rave
An initial step toward more accurate and complete data acquisition for clinical trials, the Pediatric Early Phase Clinical Trials Network (PEP-CTN) and Pediatric Brain Tumor Consortium (PBTC) will assess the feasibility of electronic transfer of laboratory data from participating institutions' local electronic health records to the Medidata/RAVE that is housed within each consortium's Uniform Resource Locator (URL). This study will assess efficiency, effectiveness, and scalability of the laboratory data extraction and transfer processes. This study will identify factors in the process that impact consortium operations, central protocol activation and implementation to the point of declaring the site data-ready.
Read the detailed description
PRIMARY OBJECITVES
- To test the feasibility of implementing automated laboratory data extraction and data transfer tools at multiple sites within PEP-CTN and PBTC.
SECONDARY OBJECTIVES
- To identify and evaluate discrepancies between laboratory data received through retrospective automated laboratory data extraction and manual data ascertainment during the original conduct of the study.
- Being tested
- Medidata RAVE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medidata RAVEOther
Data collection done exclusively through Medidata Rave. Medidata Rave is a clinical data management system being used for data collection for this trial/study. Access to the trial in Rave is controlled through the CTEP-IAM system and role assignments.
| Study group | Role | What they receive |
|---|---|---|
| Laboratory Data | Electronic transfer of laboratory data from participating institutions' local electronic health records to the Medidata/RAVE Receives: Other: Medidata RAVE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test the frequency(%) of sites that successfully submitted implementing automated laboratory data extraction and data transfer tools at multiple sites within PEP-CTN and PBTC.
Thorough evaluation of the data extraction and transfer process from each participating site to the PBTC and PEP-CTN databases. Establish feasibility of the proposed process at each site as well as the operations cores.
Measured: 18 months
Secondary outcomes (1)
Identify and evaluate discrepancies between laboratory data received through retrospective automated laboratory data extraction and manual data ascertainment during the original conduct of the study.
Laboratory results identified through automated extraction and transfer will be evaluated to determine if all laboratory results submitted as part of the therapeutic study can be identified.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start28 Aug 2021
- Primary completion31 Jul 2023
- Study completion30 Jun 2026
Why it stopped: Funding for the project ended and all analyses have been completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Accurate and Complete Data Acquisition for Clinical TrialsStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), Pediatric Brain Tumor Consortium
- Responsible party
- Sponsor
- Investigators
- Tamara Miller, MD, MSCE, Study chair, Children's Healthcare of Atlanta/Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020951
- Sponsor's protocol ID
- PEPN21EHR
- Other IDs
- PCTC-N15
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2021
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wyatt KD, Volchenboum SL. Big Data in Pediatric Oncology: Hope, Hype, Reality. Hematol Oncol Clin North Am. 2026 Jun;40(3):417-428. doi: 10.1016/j.hoc.2026.02.004.
PubMed 42270202Miller TP, Getz KD, Krause E, Jo YG, Charapala S, Gramatages MM, Rabin K, Scheurer ME, Wilkes JJ, Fisher BT, Aplenc R. Automated Electronic Health Record Data Extraction and Curation Using ExtractEHR. JCO Clin Cancer Inform. 2024 Nov;8:e2400100. doi: 10.1200/CCI.24.00100. Epub 2024 Nov 25.
PubMed 39586036
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Enable Electronic Laboratory Data Transfer Into Medidata Rave
- ClinicalTrials.gov ID
- NCT05020951
- Acronym / sponsor ID
- PEPN21EHR
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding for the project ended and all analyses have been completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI), Pediatric Brain Tumor Consortium
- Study start
- 28 Aug 2021 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An initial step toward more accurate and complete data acquisition for clinical trials, the Pediatric Early Phase Clinical Trials Network (PEP-CTN) and Pediatric Brain Tumor Consortium (PBTC) will assess the feasibility of electronic transfer of laboratory data from participating institutions' local electronic health records to the Medidata/RAVE that is housed within each consortium's Uniform Resource Locator (URL). This study will assess efficiency, effectiveness, and scalability of the laboratory data extraction and transfer processes. This study will identify factors in the process that impact consortium operations, central protocol activation and implementation to the point of declaring the site data-ready.
Detailed description
PRIMARY OBJECITVES
- To test the feasibility of implementing automated laboratory data extraction and data transfer tools at multiple sites within PEP-CTN and PBTC.
SECONDARY OBJECTIVES
- To identify and evaluate discrepancies between laboratory data received through retrospective automated laboratory data extraction and manual data ascertainment during the original conduct of the study.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laboratory Data | – | Other: Medidata RAVEElectronic transfer of laboratory data from participating institutions' local electronic health records to the Medidata/RAVE |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Laboratory data from patients previously enrolled on selected PEP-CTN and PBTC trials. Studies include ADVL1412, ADVL1312, ADVL1411, PBTC-042, PBTC-047 (Stratum 1), PBTC-050, and PBTC-051.
Key inclusion criteria (5 listed)
- Patient Data Inclusion Criteria: Specific patient clinical research data to be included in this study for retrospective data capture and analysis will originate from the following PEP-CTN and PBTC studies:
- PEP-CTN: ADVL1412, ADVL1312, ADVL1411
- PBTC: PBTC-042, PBTC-047 (Stratum 1), PBTC-050, PBTC-051 (Stratum 1)
- Participating Site Inclusion Criteria: Data from above clinical studies at the following institutions will be included in the initial pilot, with potential to expand to other sites at which patients on these studies were treated.
- Site Participation: Children's Healthcare of Atlanta - Scottish Rite and Egleston, Children's Hospital of Philadelphia, Memorial Sloan Kettering Cancer Center, Seattle Children's Hospital, St. Jude Children's Research Hospital, Texas Children's Hospital, and University of California, San Francisco - Mission Bay
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medidata RAVEData collection done exclusively through Medidata Rave. Medidata Rave is a clinical data management system being used for data collection for this trial/study. Access to the trial in Rave is controlled through the CTEP-IAM system and role assignments. | Other | Laboratory Data |
Primary outcome
Test the frequency(%) of sites that successfully submitted implementing automated laboratory data extraction and data transfer tools at multiple sites within PEP-CTN and PBTC.
Time frame: 18 months
Thorough evaluation of the data extraction and transfer process from each participating site to the PBTC and PEP-CTN databases. Establish feasibility of the proposed process at each site as well as the operations cores.
1 secondary outcome
Identify and evaluate discrepancies between laboratory data received through retrospective automated laboratory data extraction and manual data ascertainment during the original conduct of the study.
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Funding for the project ended and all analyses have been completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Derived from this study: PubMed 42270202Wyatt KD, Volchenboum SL. Big Data in Pediatric Oncology: Hope, Hype, Reality. Hematol Oncol Clin North Am. 2026 Jun;40(3):417-428. doi: 10.1016/j.hoc.2026.02.004.
- Derived from this study: PubMed 39586036Miller TP, Getz KD, Krause E, Jo YG, Charapala S, Gramatages MM, Rabin K, Scheurer ME, Wilkes JJ, Fisher BT, Aplenc R. Automated Electronic Health Record Data Extraction and Curation Using ExtractEHR. JCO Clin Cancer Inform. 2024 Nov;8:e2400100. doi: 10.1200/CCI.24.00100. Epub 2024 Nov 25.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara Miller, MD, MSCE study chair
Children's Healthcare of Atlanta/Emory University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Accurate and Complete Data Acquisition for Clinical Trials, run by Children's Oncology Group at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding for the project ended and all analyses have been completed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test the frequency(%) of sites that successfully submitted implementing automated laboratory data extraction and data transfer tools at multiple sites within PEP-CTN and PBTC. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05020951, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026; AzTrials last refreshed its copy on 30 Oct 2026.