Clinical Research InclusionCRA-MDNCT03946501
Clinical Research and Data Collection During the Investigation: Influence of a Dedicated Staff
An observational study of Clinical Research Inclusion, run by CHU de Reims at 1 site in France.
Trial summary
The aim of the study was to evaluate the interest of the recourse of a staff dedicated as CRA to data collection in clinical research Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Research Inclusion
- What is being tested?
- Data collection
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2015to 1 May 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: clinical research visit performed in Reims university hospital, with or without the help of a clinical research assistant
Who may be able to join
- clinical research visit performed in Reims university hospital between January 2010 and January 2015
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study was to evaluate the interest of the recourse of a staff dedicated as CRA to data collection in clinical research
Read the detailed description
Objectives of clinical studies are notably to evaluate new therapies, to improve diagnostic techniques, to make medico-economic decisions and to enrich scientific knowledge. Clinical studies findings can influence medical practice, or even motivate decisions by public health authorities. The rigor in their behavior is therefore an imperative to respect.
Thus, the quality of the data collected is essential. However, even if the reliability of the clinical data is guaranteed by the monitoring, the completeness of the data remains exceptional.
The increase of data required in clinical studies has led to the emergence of a specialized staff to assist investigators: the clinical research assistants. With dedicated time and specialization in data collection, they facilitate the conduct of clinical studies. However, this data collection aid has not been evaluated.
- Conditions
- Clinical Research Inclusion
- Being tested
- Data collection
- Keywords
- missing data, clinical research, clinical research assistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
| Study group | Role | What they receive |
|---|---|---|
| clinical research visit | Not described Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Missing data
Data was considered missing because of its absence when finalizing the data
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start1 Mar 2015
- Primary completion1 Apr 2015
- Study completion1 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clinical Research InclusionStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946501
- Sponsor's protocol ID
- 2018Ao003
- Acronym
- CRA-MD
- Status last verified
- May 2019
- First submitted
- 9 May 2019
- Last updated
- 10 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ghenim S, Feron T, Barbe C, Wolak-Thierry A, Jolly D. [Clinical research and data collection during the investigation: Influence of a dedicated staff]. Therapie. 2018 May-Jun;73(3):267-272. doi: 10.1016/j.therap.2017.10.003. Epub 2017 Nov 11. French.
PubMed 29198734
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research and Data Collection During the Investigation: Influence of a Dedicated Staff
- ClinicalTrials.gov ID
- NCT03946501
- Acronym / sponsor ID
- CRA-MD / 2018Ao003
- Conditions
- Clinical Research Inclusion
- Keywords
- missing data, clinical research, clinical research assistant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 1 Apr 2015 (actual)
- Study completion
- 1 May 2015 (actual)
- First posted
- 10 May 2019 (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.
The aim of the study was to evaluate the interest of the recourse of a staff dedicated as CRA to data collection in clinical research
Detailed description
Objectives of clinical studies are notably to evaluate new therapies, to improve diagnostic techniques, to make medico-economic decisions and to enrich scientific knowledge. Clinical studies findings can influence medical practice, or even motivate decisions by public health authorities. The rigor in their behavior is therefore an imperative to respect.
Thus, the quality of the data collected is essential. However, even if the reliability of the clinical data is guaranteed by the monitoring, the completeness of the data remains exceptional.
The increase of data required in clinical studies has led to the emergence of a specialized staff to assist investigators: the clinical research assistants. With dedicated time and specialization in data collection, they facilitate the conduct of clinical studies. However, this data collection aid has not been evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| clinical research visit | – | Other: Data collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- clinical research visit performed in Reims university hospital, with or without the help of a clinical research assistant
Key inclusion criteria (1 listed)
- clinical research visit performed in Reims university hospital between January 2010 and January 2015
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 |
|---|---|---|
| Data collection | Other | clinical research visit |
Primary outcome
Missing data
Time frame: Day 0
Data was considered missing because of its absence when finalizing the data
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Background: PubMed 29198734Ghenim S, Feron T, Barbe C, Wolak-Thierry A, Jolly D. [Clinical research and data collection during the investigation: Influence of a dedicated staff]. Therapie. 2018 May-Jun;73(3):267-272. doi: 10.1016/j.therap.2017.10.003. Epub 2017 Nov 11. French.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Research Inclusion, run by CHU de Reims at 1 site in France.
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 1 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: finished, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Missing data (time frame: Day 0). 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 NCT03946501, which also lists 1 linked publication.
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 10 May 2019.