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Message-ID: <faa872ca-1043-4999-9aec-cc1b27d44da5@glenbowcollege.ca>
Date: Tue, 25 Apr 2023 06:51:59 -0900
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To: regulatory@msrainc.com
From: "Jennifer McCaffrey" <email@glenbowcollege.ca>
Subject: ::EXTERNAL:: FW: BHV3500-301 first patient update and EDC training
----------------R0aBDhhGG0G0tGtmtgBXhhnh
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<html><body><div><p>Would you please check the latest contract? I have atta=
ched some extra details regarding it.<br></p></div><hr tabindex=3D"-1" styl=
e=3D"display:inline-block; width:98%"><table><tbody><tr><td><p>CAUTION: THE=
MESSAGE BELOW IS FROM AN EXTERNAL SOURCE. PLEASE DO NOT OPEN ATTACHMENTS O=
R CLICK LINKS FROM AN UNKNOWN OR SUSPICIOUS ORIGIN</p></td></tr></tbody></t=
able><div><div><p><span>Goal for FPFV has been pushed to 20Oct2020 for the =
above study at TPA CRU due to ERT system failure.</span></p><div><p><b><spa=
n>Regards,</span></b></p><p><span>Jennifer McCaffrey</span></p><p><span>Jen=
nifer McCaffrey RN., BS.</span></p><p><b><span>Site Director Tampa</span></=
b></p><p><b><span>Meridien Research, an</span></b><span><span>AMPLIFY</span=
></span><b><span> Clinical Company</span></b></p><p><b><span>Tampa Office</=
span></b></p><p><b><span>5411 Beaumont Center Blvd.</span></b></p><p><b><sp=
an>Suite # 760</span></b></p><p><b><span>Tampa, FL 33634</span></b></p><p><=
b><span>813-877-8839 ext. 1207</span></b></p><p><b><span><span>Our mission =
is to provide the highest quality clinical research in a professional, ethi=
cal, and timely manner. We are committed to providing the best possib=
le clinical care to our research participants.</span></span></b></p><p><spa=
n>DISCLAIMER:<br>This e-mail, including attachments, may include confidenti=
al and/or proprietary information, and may be used only by the person or en=
tity to which it is addressed. If the reader of this e-mail is not the inte=
nded recipient or his or her authorized agent, the reader is hereby notifie=
d that any dissemination, distribution or copying of this e-mail is prohibi=
ted. If you have received this e-mail in error, please notify the sender by=
replying to this message and delete this e-mail immediately</span></p></di=
v><div><div><p><b><span>From:</span></b><span> Micaela Forshaw <br><b>Sent:=
</b> Thursday, October 1, 2020 10:42 PM<br><b>To:</b> ; ; ; ; ; ; ; ; ; ; ;=
; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; =
; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ;=
; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; =
; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ;=
; ; Gigi Lefebvre ; Jane Shafer ; Laura Jenkins ; Jennifer McCaffrey ; Mar=
y Ann Cameron ; Jane Shafer ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ;=
; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; =
; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ;=
; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; =
; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; <=
br><b>Cc:</b> Danielle Casino ; Beth Morris ; Jeri-Anne Finley ; Meghan Lov=
egren ; Jennifer Madonia ; Jennifer Hould ; Anthony West ; Tammy Gilbreath =
; Alaina Dobos ; Mary Beth Horak (Audickas) ; Raj Dave ; Elizabeth DeLeo ; =
John Flynn ; Hiedi Gooch ; ; Permila Mackey-Foster ; Melinda Metzger-Abamuk=
ong ; ; Ije Omekam ; Lane Satterthwaite ; Diana Swanson ; Paula Turchetta ;=
Qun Zeng ; Melanie Zarycki ; BHV3500-301 <br><b>Subject:</b> BHV3500-301 f=
irst patient update and EDC training <br><b>Importance:</b> High</span></p>=
</div></div><p><span>Dear Investigators and Site Staff,</span></p><p><b><sp=
an>Due to the company level outage ERT is currently experiencing,<u>we are =
pushing first subject first visit on the BHV3500-301 study to October 20, 2=
020</u>.</span></b></p><p><span>ERT has informed us that the system will be=
online shortly, but the shipment of devices is delayed with no timeline ye=
t for normal activities to resume. Our hope is that this delay will allow a=
ll sites to have received devices prior to FSFV.</span></p><p><span>We apol=
ogize that this date needs to be shifted again and will keep everyone infor=
med as we learn additional relevant details.</span></p><table><tbody><tr><t=
d><p><span>Attached are the Site Training Slides, CRF Instructions and trai=
ning log. Below is the info for accessing the Site Training Video:</s=
pan></p><p><b><u><span>Site Training Video Info:</span></u></b></p><p><u><s=
pan>Link</span></u><span>:</span></p><p><u><span>Password</span></u><span>:=
BHV3500301</span></p><p><span>After reviewing, please complete the T=
raining Log in the attached .zip file and send toto receive access.This mus=
t be completed prior to site activation.</span></p></td></tr></tbody></tabl=
e><p><span>Thank you all for your understanding,</span></p><p><span>Micaela=
</span></p><div><table><tbody><tr><td><table><tbody><tr><td><table><tbody><=
tr><td></td></tr><tr><td></td></tr></tbody></table></td><td><table><tbody><=
tr><td><table><tbody><tr><td><p><b><span>Micaela Forshaw</span></b></p=
></td><td><p><b><span>, </span></b></p></td><td><p><b><span>M.P.H.</sp=
an></b></p></td></tr></tbody></table></td></tr><tr><td><table><tbody><tr><t=
d><p><b><span>Clinical Trial Lead</span></b></p></td></tr></tbody=
></table></td></tr><tr><td><table><tbody><tr><td><table><tbody><tr><td><tab=
le><tbody><tr><td><p><span>c: </span></p></td><td></td></tr></tbody></=
table></td></tr></tbody></table></td></tr></tbody></table></td></tr><tr><td=
><table><tbody><tr><td><table><tbody><tr><td><p><span>e: </span></p></=
td><td></td><td><table><tbody><tr><td><p><span>|</span></p></td></tr></tbod=
y></table></td><td><p><span>w: </span></p></td><td></td></tr></tbody><=
/table></td></tr></tbody></table></td></tr><tr><td><table><tbody><tr><td><t=
able><tbody><tr><td><p><span>a: </span></p></td><td><p><span>215 =
Church Street</span></p></td><td><p><span>, </span></p></td><td><=
p><span>New Haven</span></p></td><td><p><span>, </span></p></td><=
td><p><span>CT</span></p></td><td><p><span>, </span></p></td><td><p><s=
pan>06510</span></p></td></tr></tbody></table></td></tr></tbody></table></t=
d></tr><tr><td><table><tbody><tr><td><table><tbody><tr><td><table><tbody><t=
r><td></td></tr></tbody></table></td><td><table><tbody><tr><td></td></tr></=
tbody></table></td><td><table><tbody><tr><td></td></tr></tbody></table></td=
><td><table><tbody><tr><td></td></tr></tbody></table></td></tr></tbody></ta=
ble></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody><=
/table></td></tr><tr><td><table><tbody><tr><td><p><span>Now approved&n=
bsp;Nurtec ODT (rimegepant)</span></p></td></tr></tbody></table><=
/td></tr><tr><td><table><tbody><tr><td><table><tbody><tr><td><p><span><span=
>This email and any files transmitted within may contain confidential, prop=
rietary, privileged and/or private information. The information is intended=
solely for the use of the individual(s) or entity(ies) to whom it is addre=
ssed. If you are not an intended recipient, please notify the sender immedi=
ately by replying to the message and delete the message and any attachments=
from your computer (including deleting the inbox message, sent message and=
email trash). Any disclosure, reproduction, distribution or other us=
e of the message or any attachments by an individual or entity other than t=
he intended recipients is prohibited.</span></span></p></td></tr></tbody></=
table></td></tr></tbody></table></td></tr></tbody></table></div></div><br><=
hr><p>CONFIDENTIALITY NOTICE The information in this transmittal (including=
attachments, if any) may be privileged and confidential and is intended on=
ly for the recipient(s) listed above. Any review, use, disclosure, distribu=
tion or copying of this transmittal, in any form, is prohibited except by o=
r on behalf of the intended recipient(s). If you have received this transmi=
ttal in error, please notify me immediately by reply email and destroy all =
copies of the transmittal.</p></div></body></html>
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