Reporting Guidance

There is also a CONSORT statement concerning the reporting of cluster randomized trials (recall Section 5.6.2). The added complexities of these studies mean that reporting guidance specifically for these trials is appropriate (see Campbell et al., 2004). Additionally, the CONSORT group has published a statement on reporting equivalence and noninferiority randomized trials (see Piaggio et al., 2006). 

Ecological Committee on FIFRA Risk Assessment Methods (ECOFRAM), ECOFRAM ECOFRAM Aquatic Report. Guidance on Methods for Aquatic Risk Assessment Methods for Aquatic Ecological risk Assessment , June 2000. 

ECHA (2008c). Guidance on information requirements and chemical safety assessment. Part E Chemical Safety Report. Guidance for the Implementation of REACH, htq) //reach.jrc.it/docs/guidance docu-ment/information requirements part f en.pdf vers=20 08 08, 1—10. 

TSCA Section 8(e) Notification of Substantial Risk Policy Clarification and Reporting Guidance. 68 Fed. Reg. 33129, 33131 (June 3. 2003) [hereinafter 2003 Reporting Guidance]. 

At this point the differences between the 2003 Reporting Guidance and the 1978 Statement of Interpretation with respect to environmental effects are only of academic interest. 

Workplace exposures are reportable under this prong of the 2003 Reporting Guidance if there is a sudden release of a large quantity of a chemical, but known workplace exposures are not reportable. 

The 2003 Reporting Guidance requires reporting emergency incidents of environmental contamination. Those incidents are defined as ... 

The first category includes the following descriptions in the 2003 Reporting Guidance of situations when substantial risk information does not need to be reported under TSCA 8(e) because the EPA has already been adequately informed ... 

Substantial risk information that must be reported to EPA must be submitted immediately, a term that has no statutory definition in TSCA. In its 2003 Reporting Guidance, EPA stated that a person has immediately informed the Administrator if human health information is received by the EPA not later than the thirtieth calendar day after the date the person obtained such information. The EPA has said it is not sufficient for the submittal to be postmarked within thirty days, and it is up to the submitter to ensure that the EPA receives it within the required time frame. Emergency incidents of environmental contamination must be reported to the EPA by telephone as soon as the person has knowledge of the incident. That could be on the order of minutes or hours, but it would be difficult to argue that waiting a full day is contemplated. If the information is required to be, and has been, reported under another statute administered by EPA, such as CERCEA, the TSCA 8(e) report is unnecessary. Any supplementary information must also be reported immediately. 

Fed. Reg. 2162 (Jan. 12,2005) TSCA Section 8(e) Reporting Guidance Correction, Clarification of Applicability, and Announcement Regarding the Issuance Questions and Answers 70 FR 2162 8e Clarification 1-12-05... 

DOE Order 5480.23, Nuclear Safety Analysis Reports (DOE 1994a), Paragraph 8b(3)(n), as amplified by Attachment 1, Paragraph 4f(3)(d)14, of the order (Topic 14) requires a systematic inquiry into or evaluation of human factors for the facility. DOE Memorandum, Safety Analysis Report Guidance - Human Factors, DOE/DP-625 (DOE 1992), indicates that the use of the Human Factors Safety Analysis checklist will satisfy the requirements of DOE Order 5480.23 concerning human factors for existing facilities. 

DOE Memorandum, Safety Analysis Report Guidance — Human Factors, DOE/DP-625, U.S. Department of Energy, Washington, D.C., December 1,1992. 

BIKG (1995) Technical Report Guidance for the injecdon moulding of poly-l-lactide. Boehringer Ingelheim KG, Ingelheim am Rhein, Germany. 

Institution of Structural Engineers (IStructE) http //www.istructe.org.uk/ (accessed November 3, 2010). Founded in 1908 (as the Concrete Institute), IStructE publishes The Structural Engineer, technical reports, guidance, conference and symposium papers. In addition, it organizes CPD events. The library is an important specialist resource. 

In compliance with the EURACHEM report Guidance on Best Practice for the Equipment Qualification of Analytical Instruments [114,115], in general terms four areas need to be addressed as to assurance of validity, namely ... 

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