ISARIC CCP Toolkit
ISARIC CCP Toolkit
The competencies/skills presented are by no means an extensive list of staff competencies to carry out the CCP.
In all instances you must ensure that you adhere to local and national guidelines.
For training resources, visit the ISARIC CCP resources Library
.| Competency | |||||
|---|---|---|---|---|---|
| An understanding of the research | |||||
| The specific primary and secondary research aims of this study | |||||
| The clinical infrastructure requirements for the sites chosen recruitment module | |||||
| The purpose of ethics in research | |||||
| How high ethical standards, data quality and uniformity are maintained in a study | |||||
| What a cohort study is | |||||
| What the infection of interest is, how it is transmitted and how to assess the risk of infection | |||||
| Study recruitment, consent and research participants | |||||
| Understand the importance of informed consent in research and why it’s necessary | |||||
| Be able to confidently explain the study, and consent form | |||||
| Understand what to do when participants require translation of patient information sheets and informed consent forms so that the participant understands the study | |||||
| Understand the benefits and risks to participants taking part in this study | |||||
| Accurately explains to participants the benefits and risks of taking part in this study | |||||
| Understands the study’s inclusion and exclusion criteria | |||||
| Study management | |||||
| Understand the mechanisms in place for adverse event reporting at their site | |||||
| BUnderstand the follow up procedure for enrolled participants at their site | |||||
| Knows how to access the Study Master File | |||||
| Data entry | |||||
| Confident in accessing and using the electronic data capture software | |||||
| Can confidently complete Paper based case report forms (CRF) | |||||
| The web based “eCRF” | |||||
| Clinical sampling | |||||
| Understand the hygiene measures required to protect themselves when in contact with study participants including use of personal protective equipment (PPE) | |||||
| Is confident in the procedures for obtaining required clinical samples at each stage of study follow-up including; | |||||
| Procedures for serial sampling including the appropriate timings of serial samples as per the protocol (modules 2 and 3) | |||||
| Procedures for obtaining clinical specimens at baseline/presentation including blood, cerebrospinal fluid (if CNS disease), infected sites/sores, sputum, respiratory tract specimens, urine and stool or rectal swab (modules 1, 2 and 3) | |||||
| Procedures for pathogen only serial sampling (modules 2 and 3 sites) | |||||
| Procedure for additional sampling for pharmacokinetic /pharmacodynamics studies including use of the pharmacokinetic record form (module 3 sites only) | |||||
| Understands the patient specific clinical sampling guidelines including sampling volume by patient weight and cerebrospinal fluid volume guidance (see protocol) | |||||
| Laboratories and samples (skip if Module 0) | |||||
| Is confident in the documentation required for sample processing and has an understanding of input and retention of data for samples and labelling | |||||
| Understands the protocol in place for sending samples to those not listed in the Protocol and Material Transfer Agreement | |||||
| Is confident in monitoring laboratory resources and informing relevant staff of replenishments | |||||
| Is confident in the procedures for biological sample processing involving manual techniques and/or use of laboratory equipment (as specified in the protocol) | |||||
| Is suitably qualified in using the following equipment as per the requirements of the site | |||||
| Centrifuge equipment | |||||
| Serological testing equipment | |||||
| Freezers for storage of samples (at least -80°C) | |||||