Home Care Visits

Home Care Visits

Our Home Trial Support Service offers our customers and patients in a study the possibility to carry out study visits according to protocol at the patient’s home. The visits are carried out by experienced, qualified and registered nurses, in close consultation with the patient, the research site and the sponsor of the study.

CTS provides the Home Care Visits in all European countries and the United States of America.

Advantages of  Home Care Service

1. It reduces the number of hospital visits dramatically. Advantage for the patient :
Far less demanding for patient and family;
2. It raises inclusion on site by 80% and prevents from premature discontinuation of the
trial (drop-out);
3. High compliance. Fixed team of specialised trial nurses who work uniformly
in accordance with same procedures;
4. Tailor-made appointment: Patient’s diary and protocol visits schedule are
leading;
5. Best possible service for patient;
6. Population for study rises by increase of inclusion;
7. Direct communication between nurse and investigator.

Published:

“Home Trial Support Service: a flexible and comfortable clinical trial service for patients and sponsors.”

Site Trial Support

CTS places trial nurses and study coordinators in study centres. The research professional performs study-specific tasks for a given period, for a specific trial, to help ease work pressure of the research team, or to offer research expertise.

The research professional or research team may also be deployed for multicentre research,working in different research centres simultaneously.

Main tasks and skills CTS research nurses

What tasks CTS research nurses carry out depends on the particular study. Study-specific tasks are executed according to protocol and the SOP’s or work regulations. Common tasks are: taking and processing blood samples; taking blood pressure; making ECG; administering medication (injection or drip); inquiring after (serious) side effects; filling out (e)CRF and taking questionnaires. Patient safety and the quality of the collected study data are safeguarded by study-specific courses and annual ICH-GCP courses.
CTS research nurses are experienced within the field of medical scientific research (phases 1-4). They have extensive experience in oncology; blood diseases; haemophilia; influenza vaccination studies; cardiology; dermatology; lung diseases; stomach, intestinal and liver diseases; kidney diseases; but also in rare diseases like Prader Willi Syndrome, Duchenne and ALS.

ICH GCP and ISO 14155 training 

“Legislation and regulations for clinical trial with drugs and medical aids in daily practice”

Background

Clinical trials have to be run in accordance with international and local standards, as prescribed in the International Conference on Harmonisation Good Clinical Practice (ICH-GCP), WMO (Medical Research Involving Human Subjects Act) and the European Clinical Trial Directive 2001/20/EC.

Research in accordance with these regulations guarantee the wellbeing, personal rights and safety of the patients, as well as ensuring reliable research data. Hence, all researchers and other participants are required to act according to these regulations.

Accreditation

  • Accreditation Bureau Algemene Nascholing (PE-online) for medical specialists;

  • V&VN for nursing specialists
  • Transcelerate BioPharma
  • Recommended by EMWO ( Dutch Examination Committee GCP exam)

At your request, our courses can be accredited for other professional associations.

 

What do we offer?

  • One-day course for experienced research employees and doctors
  • two-day course for those starting out in clinical research
  • Refresher course (on demand)
  • CRA training
  • Tailored courses
  • In-company training

How do we work ?

Our courses are always preceded by an entry test. The participants’ exit levels are also tested. Courses may be held at CTS, at an external location or at your own institute. Active participation by the participants is highly encouraged.

Content ICH GCP / ISO 14155 training

During the course we focus on legislation and regulations for clinical trial with drugs and medical aids in daily practice. We pay extensive attention to:

  • Practical and general knowledge about research
  • History of clinical trials and legislation
  • Different phases in clinical research
  • Different types of clinical research
  • General and specific terminology that research members will deal with
    Privacy Legislation (Wet Bescherming Persoonsgegevens)
  • ICH-GCP regulations, WMO and European Clinical Trial Directive
    Trials with drugs and medical aids

Tasks and responsibilities of parties involved, according to ICH-GCP regulations

  • Preparations
  • Selection of research center
  • Medical Ethical Committee (Medisch Ethische Toetsingscommissie)
  • Initial monitoring visit
  • Essential documents
  • Reliability of research data
  • Selection of patients
  • Informing patients
  • Visiting patients
  • Study-specific measurements
  • Monitoring visits
  • Verification of source data
  • Drug accountability
  • Data queries
  • Quality control on various levels, among which audit and inspection
  • Close-out visits and archiving

Tailor-made courses at your location

We can also plan courses at your request. This training can be delivered at any location, including your own. Please contact us for the possibilities. In-company and tailor-made courses are fully adapted to your wishes.

Minimum number of students: 5.

Costs and conditions

One-day ICH-GCP training: EUR 495 (excl. 21% VAT)
Two-day ICH-GCP training: EUR 795 (excl. 21% VAT)
Includes use of training facilities, course syllabus, coffee & tea, lunch and snacks. The training requires at least 5 participants to take place. Maximum number of participants: 15.
The cost for in-company training is dependent on the content of the course and the number of participants (min. 5). Please contact us for the possibilities and a quote.
Payment not later than twee weeks before start of training.

Participants

Trainings

Evaluation

Subscribe now online !
Confirmation

After receiving the registration form, CTS will send you a confirmation and invoice. Payment is due within 30 days of the invoice date.

 

Cancellation

The set-up of the course requires your presence on both days. In case of absence, we may find an alternative course day for you at another date, possibly at another location.

 

 

 

Terms and Conditions
  1. Training fee one-day course: €495 (excl. 21% VAT); two-day course €795 (excl. 21% VAT).
  2. Registration for a training at Clinical Trial Service BV in Losser, hereafter to be called CTS, is completed when CTS has received the completed registration form via the website.
  3. The participant declares by electronically submitting the registration form to agree without reservations to CTS’s terms and conditions.
  4. After receipt of the registration form CTS will send a confirmation and invoice by return.
  5. CTS will confirm the course dates not later than two weeks prior to the training.
  6. In case the training is cancelled, CTS will refund any received training fees, or participants may register for an alternative training.
  7. Participation may be cancelled by the participant until three weeks prior to the training without additional costs. In case of cancellation within three weeks prior to the training, the participant is obliged to pay the training fee.
  8. The participant has the right to be substituted by another participant, provided that CTS is notified in advance, and the substituting participant has agreed before the start of the course to the terms and conditions.
  9. Payment is due within 30 days after the invoice date, but before the start of the course.
  10. CTS has the right to refuse a participant to the course, in case and as long as the payment of the participant’s fee has not been confirmed.
  11. CTS does not agree to the participant’s, participant’s company’s or organisation’s payment conditions, unless confirmed in writing by CTS.
  12. CTS will not be liable to the participant in any way for damages resulting from advice or application of the course material and/or other material provided to the participant by CTS.
  13. The complete course content is copyright-protected, which the participant acknowledges unconditionally. The participant is not allowed to pass the course material on to third parties.
  14. It is forbidden to use CTS course materials for one’s own courses.

Testimonials ICH GCP en ISO 14155 training:

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