OMB Meeting Book_9-11-14

Vitamin A & E MLT Protocol For ERP Use Only DO NOT DISTRIBUTE

Figure 1 .

Flow Diagram of the proposed work required for the collaborative trial.

Read and become familiar with the Protocol and Method.

Make sure all health and safety procedures are understood and any specific laboratory requirements are fulfilled.

Day 1

Source all chemicals and reagents required for the method.

Set up HPLC system and install column as per method

Prepare solutions, mobile phases and Stock Reference Calibration Standard

Perform instrument specific system suitability checks.

Prepare the Practice samples with a freshly diluted 6 point calibration curve.

Day 2

Set up sequence and run The sample set

Complete the results template and submit to the study director for review. Let the SD know of any issues with sample preparation or analysis

Note: The following two days analysis need to be performed on consecutive days .

Following approval of the practice samples, prepare and run the collaborative test samples with a freshly prepared 6 point calibration curve. Include System Suitability checks and include the practice samples as control samples.

Day 3

Review Analytical run from Day 3. Prepare and run the collaborative test samples with a freshly diluted 6 point calibration curve. Include System Suitability checks and include the practice samples as control samples.

Day 4

Check results for “correctable outliers” and send the complete set of results to the SD. Include system check data.

Day 5

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