Protocol documentation

The purpose of an import tolerance and its impact on the global registration process should be explained. The official protocol document should be reviewed in general, and practical discussion should center on the worksheet and the hands-on tasks that the personnel at the meeting will be performing. 

EPA is also planning to issue a second protocol document on how to apply these protocols for different purposes. This document will provide guidance on where in the house the measurement should be made and the appropriate sampling times for each method which will vary depending upon the purpose of the measurement. 

Validation protocol Document describing the specific item to be validated, the specific validation protocol to be carried out and acceptable results, as per acceptance criteria... 

No matter what its design, a well-planned clinical trial requires development of a suitable trial protocol prior to its commencement. The protocol documents outline all pertinent aspects of the trial (Table 2.8) and should be made available to trial participants and other interested parties. A core prerequisite of any trial is that participants be fully informed regarding the intervention and any likely associated effects. 

According to cGXP requirements, this plan should be reviewed and approved. Quality assurance involvement is recommended. It would be possible to generate a combined plan/protocol document that includes all information described in this chapter. The actual results generated during validation have to be added to complete the protocol. 

Reference 1, Reactive Chemicals Program Guideline and Reference 11, Reactive Chemicals/Process Hazard Analysis Introduction and Protocol document.)... 

Protocol Summary. A summary of the protocol documentation. including an analysis of the test results, the compliance audit of the system, and any system modifications should be submitted to the computer systems validation committee for their review and approval. It is recommended that the system not be used until final validation approval is received from the committee. 

In fact, method validation is merely the final step in the dynamic process of method development. The emphasis must be placed on the development stage, since any well-developed method can be successfully validated. Initial method development must therefore be undertaken with both the regulatory and technical requirements of validation in mind. While the emphasis is placed on method selection, sufficient development time is provided to ensure that the method meets both its technical and regulatory requirements. Only after this development stage is the testing procedure and validation protocol documentation finalized. 

All European countries require, in common with the United States, and in conformity with the Declaration of Helsinki, that ethics committees (the European version of institutional review boards in the United States) review protocols from phase I-IV and the general conduct of trials outside the formal protocol document. However, there is wide variation in Europe as to how this procedure is enacted. In countries such as France, Spain and Germany, there is a national system of ethics committees that duplicate similar work at a local level. In the United Kingdom, there are a wide variety of ethics committees, such as commercial committees, those set up by the Royal College of Physicians, and those run by local area health authorities or hospital trusts. 

Feed and water used for the animals shall be analyzed periodically to ensure that contaminants known to be capable of interfering with study and reasonably expected to be present in such feed or water are not present in levels above those specified in the protocol. Documentation of such analyses shall be maintained as raw data. 

INTRODUCTION OPERATIONAL ISSUES A. Introduction Protocols Documentation Schedules Stability Reports Audits and Inspections... 

When this information is agreed to, the protocol document should be signed by the study coordinator and by the testing laboratory management, signifying agreement to complete the study as designed. 

Systems specifications provide all the information needed for the technical implementation of the system. This includes hardware, networking connections, and backup requirements as well as all information needed to install, operate, and qualify the performance of the system. It generally includes all of the qualification protocol documents (installation, operation, and performance qualifications) created during the validation process. 

Protocol Document for recording data establishing accountability for completed actions. 

Montreal Protocol documents, concerning the phase out of ozone depleting chemicals are available at http //www.epa.gov/history/topics/ montreal/index. htm... 

---