To obtain whole blood from healthy volunteers for the purpose of preparing calibration, quality control or other samples for analytical methods (e.g. HPLC and LC-MS/MS).
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Not applicable
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
N.A.
Secondary outcome
N.A.
Background summary
See section C4.
Study objective
To obtain whole blood from healthy volunteers for the purpose of preparing
calibration, quality control or other samples for analytical methods (e.g. HPLC
and LC-MS/MS).
Study design
Healthy male or female subjects will be recruited to donate blood (with a
maximum of 500 mL every 10 weeks), with a maximum of 5 (men) and 3 (women)
times a year. The blood donation procedure will be performed at QPS Netherlands
B.V.
Study burden and risks
The blood collection procedure is not dangerous, but may cause discomfort or
bruising. Occasionally, fainting, bleeding or an infection at the blood
sampling site can occur.
Petrus Campersingel 123
Groningen 9713 AG
NL
Petrus Campersingel 123
Groningen 9713 AG
NL
Listed location countries
Age
Inclusion criteria
Provision of written informed consent.
Male and female 18 * 65 years of age, inclusive.
Healthy according to the normal procedures according to medical history, physical examination, laboratory values (Hb content) and vital signs, unless the investigator considers an abnormality to be clinically irrelevant.
Minimal weight of 50kg
Exclusion criteria
A history of, or presence of diseases or other conditions in which no blood donation can take place (as judged by the investigator).
Blood donation in the previous two months.
Evidence of having hepatitis or being HIV positive.
Current abuse of alcohol or drugs.
Pregnancy.
Positive drug screen, according to QPS work instructions.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60791.056.17 |