sample submission form for viral clearance studies · sample submission form for viral clearance...

Sample Submission

Form for

Viral Clearance

Studies

This tutorial will provide tips for completing WuXi AppTec’s

Sample Submission Form for Viral Clearance Studies in HTML format.

It is required that all applicable areas of this form be completed and

that the form be included in any sample shipment for viral clearance studies.

Using the HTML forms on our website ensures that you are submitting your samples

with the most current version of the form, which helps prevent possible compliance issues.

Table of Contents • Accessing the Form on our Website

• Clearing Information from a Previous Session

• Company and Contact Information

• Test Article Information

• Comments

• Test Articles in Shipment

• Other Materials in Shipment

• Sample Submission Authorization

• Printing / Saving

• Creating and Completing Multiple In-Progress Forms

• Storing Multiple Versions of the Form

Accessing the Form on our Website

1. Go to our website: wuxiapptec.com.

2. Click on the “Client Support” tab at the top and then select “Test Request/Sample Submission Forms” from the left-hand navigation panel.

3. When the page opens, click on the Sample Submission Form for Viral Clearance Studies.

NOTE: For best experience when using our web-enabled/HTML forms, use Internet Explorer as your web browser.

A convenient feature is that your browser will store the most recent data you have entered.

Click the Reset Button in the top right corner of the form if you need to clear out information from a previous session.

Clearing Information from a Previous Session

Clicking on the bright green question mark will open this tutorial PDF file for your reference.

Accessing This Tutorial

Company and Contact Information

Enter your Quote Number, the Protocol Number, your Account Number and your P.O. Number. You can find the quote number on the upper right hand corner of your WuXi AppTec price quote. Your account number can be found there also.

With this information entered, the company name and address will populate.

Next, add contact name, phone number and email address. The contact will be the person who will receive the final report, and will also be the person contacted by the lab if there are any questions.

Provide the same information for a secondary contact if applicable/needed.

1. Specify the Molecule / Product Name. A separate completed form is required for each individual shipment sent to WuXi AppTec. This field is limited to 255 characters.

2. Specify the species of origin the sample were derived from (examples: mouse, human, monkey) and the cell line.

3. Select the current stage of submission of your test article.

4. Select the intended type of regulatory filing.

Test Article Information

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Comments

Include in the Comments section any additional information or instructions. Examples might be:

• Return shipping temperature monitor (e.g., TempTale) in provided

self-addressed envelope

• Return shipping container to _______

• After thawing, remaining samples can be stored at 2-8° C

Test Articles in Shipment

FOR EACH TEST ARTICLE:

1. Enter the test article identification on label. This is used to verify that the appropriate vessel has been submitted. Please insure the content matches the vessel label exactly.

2. Enter the equivalent test article listed in the WuXi AppTec protocol.

3. Provide the test article matrix / buffer conditions.

4. Specify the # of containers, volume per container, storage conditions and storage conditions after thawing. Indicate if remaining material is to be returned.

If you have more than 9 test articles, click on the “Check here if more space is needed” box at the bottom of the page and another page will appear for entering the additional test articles.

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Other Materials in Shipment

FOR EACH OF ANY OTHER MATERIALS INCLUDED IN SHIPMENT (e.g., buffers, columns, nanofilters):

1. Enter the material identification, ensuring it matches the item’s label. This is used to verify that the appropriate item has been submitted.

2. Specify the # of containers, volume per container, storage conditions, and buffer conditions.

3. If you have more than 25 materials, click on the “Check here if more space is needed” box and another page will appear for entering the additional materials.

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Areas with grey background are for WuXi AppTec use only.

In the appropriate text fields, enter the Print Name and Date. Note that a actual signature – to be executed once you have printed out the form – is required for testing to be initiated.

NOTE: If you’re not ready to sign and want to come back to the form later, you can close the form and your browser history will store the information that you entered. The next time you open the form through your computer’s browser, you will see the input from your previous session.

Sample Submission Authorization

See printing

instructions

on next page

• To print or save a copy of the form, click the icon.

• You will see a dialog box with your printer options.

• If you want simply to print a copy, select your printer and click the “Print” button.

• To save a file copy, designate your printer as “Microsoft XPS Document Writer” and click “Print.” Choose location and update file name. Click “Save.”

• If you have Adobe PDF Writer, you can choose that as your print option and save the file as a PDF.

Printing / Saving

Once you have your

form completed, you

will need to print a

copy to include with

your shipment.

Form #1: http://trf.apptecls.com/TRF/TRF/ViralClearanceStudies

Form #2: http://trf2.apptecls.com/TRF/TRF/ViralClearanceStudies

Form #3: http://trf3.apptecls.com/TRF/TRF/ViralClearanceStudies

Form #4: http://trf4.apptecls.com/TRF/TRF/ViralClearanceStudies

Form #5: http://trf5.apptecls.com/TRF/TRF/ViralClearanceStudies

Creating and Completing Multiple In-Progress Forms

If you are working on one form and want to have a second form open at the same time, have your browser open a new tab/window. (This will display your browser’s home page). Copy the URL from the address bar in the tab/window of your original form and paste it into the address bar of your new tab/window. Then, type a “2” immediately after the first “trf” in the address bar — ... trf2.apptecls.com... — and click “Go” or hit your return key. A new form will open. To open additional forms, follow these same steps and change the “2” in the browser address bar to the next available — “3” or “4” or “5” — up to a total of 5.

1. Click on your “Favorites” icon. (Using Internet Explorer, it will be the star located in the upper right corner of your web browser.)

2. Select “Add to Favorites.”

3. Name the current form and click “Add.”

4. Your “Favorites” listings will now include

the added form.

Additional versions of in-progress forms

can be similarly added to your Favorites

– using different names – enabling easy

access to each.

Storing Multiple In-Progress Forms

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Thank you from all of us at

WuXi AppTec for entrusting us

with your important testing.

If you have any questions, please

contact your WuXi AppTec Account Manager.