**Validation Standardization Questionnaire**

*[Purpose of questionnaire]{.underline}: We are embarking on an effort
to define the minimum number of samples needed to reliably validate DNA
typing procedures. As part of this effort, we are conducting a survey of
standard practices currently used by practitioners in forensic DNA
laboratories. Your honest responses to the following questions will help
the entire community as we compile this information. Results will be
summarized at the Promega meeting in October 2004 and made available on
the NIST STRBase web site.*

[General Questions]{.underline}

> What does the term validation mean to you?
>
> (define in a single sentence if possible)
>
> How do you know when you are finished validating a kit, instrument,
> software, or procedure?

What steps are needed in internal validation and how many samples should
be run at a minimum?

-   Precision studies \_\_\_\_\_\_\_\_\_\_(indicate types of samples
    --i.e., ladders), \# samples/run \_\_\_\_\_\_\_\_\_\_; \# runs
    \_\_\_\_\_\_

-   Sensitivity studies\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_, what range?
    \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

-   Mixture studies \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ what mixture ratios
    are needed? \_\_\_\_\_\_\_\_\_\_\_\_

-   Non-human DNA studies \_\_\_\_\_\_\_\_

-   Non-probative cases \_\_\_\_\_\_\_\_\_\_\_\_

How many total samples do you think it takes to internally "validate" a
new forensic kit?

-   10

-   50

-   500

-   Other: \_\_\_\_\_\_

How many samples are necessary to determine heterozygote
ratios?\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Stutter
values?\_\_\_\_\_\_\_\_\_\_\_\_\_\_

How many different sets of samples are needed?\_\_\_\_\_\_\_\_\_\_ Do
they have to be run over a particular time period?\_\_\_\_\_\_\_\_

How are validation, training, and proficiency testing related to one
another?

Do you think that the process of validation can be standardized? **Y or
N**

[Specific Needs]{.underline}

Where do you look for guidance currently in terms of
validation?\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

What are some kits, software, instruments that you are considering for
validation in the next year?

+--------------------------+----------------------+--------------------+
| **[Commercial            | **[Sof               | **[Analysis        |
| Kit]{.underline}**       | tware]{.underline}** | Instrum            |
|                          |                      | ent]{.underline}** |
+--------------------------+----------------------+--------------------+
| -   Extraction:          | -   Genotyper for    | -   ABI 310        |
|                          |     Windows          |                    |
|   \_\_\_\_\_\_\_\_\_\_\_ |                      |                    |
+--------------------------+----------------------+--------------------+
| -   DNA quant:           | -   GeneMapper       | -   ABI 3100       |
|                          |                      |     *Avant*        |
|   \_\_\_\_\_\_\_\_\_\_\_ |                      |                    |
+--------------------------+----------------------+--------------------+
| -   STR amp kit:         | -   TrueAllele       | -   ABI 3100       |
|                          |                      |                    |
|   \_\_\_\_\_\_\_\_\_\_\_ |                      |                    |
+--------------------------+----------------------+--------------------+
|                          | -   Other:           | -   ABI 7000       |
|                          |                      |                    |
|                          | \_\_\_\_\_\_\_\_\_\_ |                    |
+--------------------------+----------------------+--------------------+
|                          |                      | -   Other:         |
|                          |                      |     \_             |
|                          |                      | \_\_\_\_\_\_\_\_\_ |
+--------------------------+----------------------+--------------------+

[Outcome of this Study]{.underline}

> If a standard protocol or set of guidelines existed for validation,
> would you use it? **Y or N**
>
> If a standard set of samples existed for performing validation
> testing, would you use them? **Y or N**

Other
Comments:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

[Contact Information]{.underline}

Please provide name and email address for follow-up questions if needed
(will not be included in final summary so as to keep all results
anonymous). Name: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Email: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_