Notification requirements, contracts

The notification required by this section should be in writing. The form of the writing is not important from a GLP standpoint, but it may be advantageous to put the notification into a legally binding document (e.g., contract). Alternatively, the notification may appear, for example, in a study protocol signed by the sponsor or in a letter from the sponsor to the contractor. 

A. This provision in the construction asbestos standard requires building and facility owners to notify tenants who will occupy building areas of the presence, location, and quantity of ACM and PACM in their spaces. This provision is triggered when any construction work, as defined by 1926.1101, is planned, per paragraph (k)(2)(i). The notification requirement is not limited to situations in which a disturbance of ACM or PACM will be taking place in the presence of the tenant. Tenants must be informed in advance in order to protect themselves from asbestos hazards, and so they may, in turn, inform any subtenants, housekeeping services, or other maintenance or construction employers that may be contracted by the tenants to perform work in the leased space where there is the potential for contact with ACM or PACM. 

The standard also has notification requirements should any unique hazards occur because of the contract owner or operator s work, or of any hazards are found by the contract owner or operator s work. 

An outline of the data from non-clinical studies must be submitted to the PMDA with the protocol for the proposed clinical study before commencing the clinical trial. A notification is required for each protocol. The list of items required for Clinical Trial Plan Notification is shown in Table 23.4. Furthermore, supplementary data must be added on entry to subsequent clinical phases, that is, general clinical trials and comparative trials. Such data are reviewed by the PMDA, and for this purpose the sponsor must wait for 30 days after submitting the initial notification before executing a contract with the medical institute. For a subsequent notification, the review period is reduced to 14 days. The notification also... 

Some contract laboratories and professional consultants (e.g., veterinary ophthalmologists and pathologists), may not be familiar with the GLP regulations. In such cases, mere notification of a requirement to provide GLP-compl3dng services may not be sufficient. It is advisable to spend time with contractors and professional consultants to review in detail the GLP requirements that will apply to the work they will perform. It is especially important to review with them the GLP requirements for documentation and document retention. 

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. 

Standards can have a restrictive effect on new materials as well. The FDA now requires that if a company cites a standard in its premarket notification, a Form 3654 must be completed, which is intended to detail to the Agency the extent to which the standard was applied. The form can be a grueling exercise if not considered at the beginning of letting the contract for testing or if the impact it may have on the submission is not properly understood. The form must include details of any adaptation of the standard to the device under review, deviations from the standards, requirements not applicable to the device, and the name and address of the test laboratory or certification body involved in assessment of conformance to this standard. If this information is not present in the laboratory report, the applicant must provide the information as an attachment to the form for each standard cited. For many standards, completing this form has become an onerous task. Unfortunately, without this level of disclosure, it can be difficult for the FDA to understand the degree to which the biotextile conforms to the claimed standard. Because such standards citations can become product claims of performance, such detailed information is necessary. 

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