Recruiting and screening male and female volunteer patient groups
Research type
Research Study
Full title
Recruiting and Screening Male and Female Volunteer Patient Groups, to a Panel, for Consideration in Future Respiratory Clinical Research Studies
IRAS ID
249204
Contact name
Muna Albayaty
Contact email
Sponsor organisation
PAREXEL INTERNATIONAL
Research summary
The screening protocol will allow PAREXEL to recruit and screen patients with respiratory conditions in order to build a suitable respiratory panel for forthcoming respiratory studies. Those suitable will be invited to attend study-specific screening only when both ethical and regulatory approvals have been granted.
Before these subjects are screened for a respiratory panel, they will be fully informed and will give written consent. All subjects will be recruited and screened in accordance with PAREXEL standard operating procedures (SOPs) and the International Conference on Harmonisation (ICH) Guideline on Good Clinical Practice (GCP). The respiratory panel screening procedures will usually consist of lung function tests including spirometry and reversibility testing, both of which are used in the majority of respiratory studies in order to evaluate suitability for enrolment. Any subjects that are deemed suitable for inclusion in this respiratory panel will be asked to provide details of their general practitioner (GP), so that written notification of their potential participation in a clinical study can be sent along with a questionnaire to obtain a medical history. A medical examination, 12 lead electrocardiogram (ECG), and vital signs measurement will also be included in the respiratory panel screening process. Subjects will be confirmed suitable on the basis of the respiratory panel screening procedures. Most studies require a medical history, medical examination and 12-lead ECG.
REC name
West of Scotland REC 3
REC reference
18/WS/0109
Date of REC Opinion
26 Jun 2018
REC opinion
Further Information Favourable Opinion