Training contract staff

Many of the technical requirements of the Standard are covered in Chapters 4 to 7. The analytical requirements, including choosing a method and method validation, are covered in Chapter 4. The other measurement requirements, such as calibration, traceability and equipment qualification, are dealt with in Chapter 5. Some of the general issues not covered elsewhere are mentioned in the following sections. It has already been mentioned that staff should be trained and proven to be competent to carry out the testing. This applies to permanent and contracted staff. The laboratory should have a job description for all members of staff. There are more stringent requirements on staff who are also able to provide customers with opinions or interpretation of the results. 

Training records must be maintained for all staff involved in the implementation, operation or support of the infrastructure. This will include contract staff and third-party arrangements. 

System safety support tasks are those tasks, normally performed by the safety staff, required to support and maintain system safety efforts, including verification and tracking, training, contracting support, and data collection and... 

Where contract staff are hired on a temporary basis and are put to tasks for which training is considered necessary for full time employees, the employer is required to give those temporary staff the same training. 

In addition to the plant workers, others may benefit from some special training related to the toll. It may be advantageous or required to consider laboratory personnel, technical support staff, management and others when planning training. Again, the contract may be the way to define this and document responsibility. 

Names and training records of staff involved in sampling and analysis, or details of contract analysts and any quality standards/accreditation schemes with which they comply. 

Key technical staff become unavailable for the toll or leave the company. Attempt to interview and extract key information from the persons prior to their departure. Arrange for an overlap period for the key person and their replacement. Train the replacement. Ensure the replacement person is given access to the historical records of the toll contract, technology package, MOC packages, and incident investigations. 

Lead CRA—The lead contract research associate is usually responsible for interfacing with field monitors and addressing investigator non-compliance. They review field reports provided by field staff- and determine adequate follow-up to problems that have been identified by the field staff"as well as investigators. Clinical QA must ensure that the lead CRA is adequately trained to respond comprehensively and in a timely manner. It must also be formally trained on the notification process required when patient safety or data integrity is in question. 

It is ultimately the sponsor s responsibility to ensure that cGCP is followed in its clinical trials, even though some of the work is contracted out to CROs and other service providers. With regard to analytical laboratories, GCP guidances require that all laboratories have full documentation, data-audit trails, standard procedures, trained staff, archives of samples and data, and routine quality assurance inspections (Prokscha, 2007). If multiple laboratories were to be used, the sponsor would need assurance that GCP requirements were met for every one. In contrast, if a central laboratory is used and all samples are shipped to it, the sponsor only needs to check GCP compliance at that laboratory. 

Centralizing clinical research operations Standardizing contracts and operating procedures Training and accrediting staff... 

Cnrriculnm Vitaes (CVs) for permanent staff are nsually kept by the Human Resources Department. This is not necessarily the case for contractors, consultants, and temporary staff. Their CVs, typically retained by the responsible manager, can be easily lost when individnals move on to new contracts. One way to systematically capmre such training records for contractors, consultants, and temporary staff is to attach them as appendices to Validation Plans or Vahdation Reports. 

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