Debra L. Green, RQAP-GLP

NAICC Annual Meeting

St. Louis, MO

January 19, 2017

Relatively consistent between field trials Assuming training and SOPs are followed

Easy to read (legible)

Easy for Sponsor to summarize data

Bottom line – they’re not going away

Is data being collected directly into the program or transcribed from a paper notebook? Or is it a combination of both?

If collected directly into the system, this is the raw data.

If transcribed: Must be identified as transcribed Must be checked against originals for transcription

errors

What are the deliverables?

If there is a summary document generated at the field site, does it need to be reviewed by QA?

Easiest / fastest /most efficient and cost effective if all data formats are reviewed at the same time

Verify that the validation document is maintained or archived for each computer where the software is installed.

Need new validation for software version updates, update of computer operating system, and major hardware changes, at a minimum.

Each sponsor company has training documents and/or SOPs for how to use their e-notebooks

They may also have an SOP or checklist for how to audit the electronic data

Changes made per GLP

Person making change identified

Reason for change

Signed/dated when change is made

Original information retained

All e-notebooks require that periodic updates must be sent to sponsor, or study management company either through automatic updates or by sending manually.

No matter what e-notebook information is requested, the signed paper protocol takes precedence for the conduct of the trial.

E-notebook is a tool

Review protocol and all available amendments.

At a minimum:

Chain of Custody document for Test Substance

Sample shipping records / chain of custody

Bill(s) of lading

Correspondence

Printed copies of emails

Phone logs

Any documents required to reconstruct the activities of the trial Also documents that study director is informed of

study activities and maintains control of study

List of SOPs used in the trial**

Copies of chemical storage temperature records

Copies of sample storage (freezer) temperature records

Copies of weather data, monthly and historical

Check for completeness, correct time periods and correct transcription to e-notebook

Data gaps require an exception to GLP

CVs/training records

Copies of SOPs

Equipment use/maintenance logs

May be provided as annual facility data package

Correct method used?

Check calibration and mixing calculations

Timing and interval(s)

Pre-emergence or at planting – may be broadcast to bare ground, banded or in-furrow. Check dates against planting date in e-notebook.

In furrow at planting, Banded applications, application made between rows with shielded sprayer – refer to protocol for how to calculate application rate. If unclear, contact SD or SD’s QA.

Treated seed – calculate application rate from calibration of planting equipment, seed treatment rate and plant density

Airblast Applications, Broadcast application made with hand boom or with tractor mounted equipment

Check calibration and mixing details / calculations

Additives / rates

Correct PHI timing or growth stage

Sample size, number, quality

Sample handling

Verify that samples have been documented as shipped

Retain samples shipped or destroyed

Check for: Notebook receipt

Notify SD of applications, harvest dates

Notify lab or processing facility of shipment

Lead QA copied on audits, if required

Check for documentation of Test Substance return, disposal, or removal from GLP storage

Pesticide history Transcription –units

Maintenance Chemicals

Cultural practices

QA Audit, report to PFI, PFI Management (if applicable), Study Director, Study Director Management

PFI makes corrections, then copies paper data for archive and backup of e-data for retention as required by protocol

PFI sends the sponsor-approved, finalized e-notebook (and supporting paper data) to SD

FREDDY is going away and being replaced by Delphi Pisar

Monsanto SOP AG-EQ-1007-002

Field Trial Manager eFTN User Guide

Syngenta SOP 13.11.1 “FERN Electronic Field Trial Notebook”

SOP13.6 r 5 “In-Progress Quality Assurance Inspection Reports From Contract Research Organizations”

Updated version being rolled out soon to users

Use site QA (read only) log in.

Multiple site QA issues Trial Independent data

If samples are harvested or cut on one date and sampled on another, be sure correct information is entered in e-notebook in proper field

Compendium of Pesticide Common Names

Growth Stages of Mono and Dicotyledonous Plants