HOVON Clinical operations
HOVON Clinical operations team is responsible for all operational aspects of a HOVON trial. This includes:
- Project Management
- Central data management
- Monitoring
- Statistics
- Pharmacovigilance
- ICT
- QA
Activities
The activities of the Clinical operations team broadly consist of the following components:
Project management
The submission coordinators are responsible for the submission of the trial in CTIS.
Submission dossiers for ethical committees and authorities outside of the EU are prepared by the Clinical operations team in a way that the national trial coordinator only needs to translate the patient specific information and add their national obligatory documents to the dossier. The Global Clinical Project Manager (CPM) is in the lead of the trial and coordinates the trial internally with all teams and is in close contact with the PI and funder. A trial team, consisting of a trial assistant, central data manager, monitor, statistician, IT developer and pharmacovigilance officer, develop all trial documentations like manuals and the database necessary for capturing the patient data correctly according to the protocol.
The Global CPM and trial assistants are responsible for checking the mandatory site documents in order to activate participating sites.
Central Data Management
Numerous Dutch and foreign sites participate in HOVON trials. All these sites fill out the relevant clinical data in HOVON database of the specific trial. Subsequently, the data of the patients in the trial is evaluated. If there are uncertainties or inconsistencies in the data set, queries are sent out to the sites. Once the intended numbers of patients in the trial have been achieved, and all data are correct, the database is passed on to the statistician.
As well as evaluating the data, the data managers are also involved in setting up specifications for the database and checks, writing instructions on how to fill out electronic Case Report Forms (eCRFs) for the site and processing details from PA Review, Cytogenetics review and Quality of Life questionnaires.
Monitoring
Each trial needs to be monitored. Based upon the risks of each trial, performed monitorplan is developed. The HOVON monitors are not only involved in study monitoring, but also in reviewing the Dutch HOVON sites on the echelon criteria. They act as a bridge between sites study team, making sure that the sites perform according to contract. The monitor also provides feedback from the sites to the Global CPM in order to increase the quality in conducting the trial.
Statistics
The statistician is involved from first draft of the trial. Not only do statisticians assist in designing and structuring the trials, they also produce a statistical analysis plan and set up the programming scripts for statistical processing. During the trial, the Principal Investigator, data manager and statistician regularly consult on the data, data collection and evaluation. The statistician is above all responsible for ensuring that the various analyses of the data set are implemented, so that based on the statistical reports, publications can be generated.
Pharmacovigilance
The pharmacovigilance is responsible for evaluating the patient safety data such as Serious Adverse Events (SAE), Dose Limiting Toxicities (DLT) and Adverse Events of Special Interest (AESI). They will closely cooperate with the principle investigator to analyze if an SAE is also a Suspected Unexpected Serious Adverse Reaction (SUSAR) and report the SUSARs to the applicable bodies.
ICT
ICT is mainly involved in the set-up of the data base for each trial according to the specifications designed by Central Data Management. This consists of developing CRFs and creating automated checks on data consistency. Moreover, they set up a notification system so that all local parties are informed about the enrollment of new patients or other events that are generated in the system and need certain action(s) to be performed by the site. Next to setting up trial specific operations, ICT is also involved in the Trial Management System, that supports the trial team and provides insight in the trial execution and the HOVON website.
QA
The quality advisors are responsible for the processes and systems that must continuously improve and safeguard the quality of all facets of clinical scientific research carried out by HOVON. The quality advisors are (partly) responsible for the correct execution of studies within HOVON so that the legal requirements in the field of quality, safety and GCP (Good Clinical Practice) are met.
Contact
If you have any questions regarding the operation of a trial, please contact the Global CPM mentioned in the trial section. If you have any general questions on trials, please contact us:
Telephone: +31 (0)10 704 1560
Email: HOVON@erasmusmc.nl
Attn Secretariat; roomnumber EE2155
P.O. Box 2040
3000 CA Rotterdam
The Netherlands