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Synta Pharmaceuticals9090-08
Virginia Castillo
Agenda
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1. BARC Project Team 2. Central laboratory services3. Central laboratory approach4. Material flow chart5. Trial-specific material6. Sample handling7. Shipping of samples8. Data integrity9. Reporting
BARC Project team
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Virginia CastilloProject Manager516 719 [email protected]
Jennifer CamejoProject Manager516 719 [email protected]
Central lab services
•Investigator/Monitor information (manual & leaflets)
•Supplies (sampling & shipping materials)•Sample shipment•Sample analysis•Sample storage•Data management•Customized reporting•Technical support
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Central lab approach
• LDH
• LDH isoforms
• Archived tissue/blocks
• PK
• Pharmacogenetics (PG)
• Biomarkers
Ambient shipment to BARC
Frozen shipment to BARC
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Laboratory tests:
Screening Treatment Period
Within 4 Weeks of
randomiza-tion
Cycle 1 Cycle 2 Cycle 3 Cycle 4 Cycle 5 Cycle _
Day 1 (± 3 days)
Day 15 (± 3 days)
Day 1 (± 3 days)
Day 1 (± 3 days)
Day 1 (± 3 days)
Day 1 (± 3 days)
Day 1 (± 3 days)
TESTS TO BE PERFORMED AT BARC
LDH X X X X X X X
LDH isoforms X X X X X X X
TESTS TO BE PERFORMED BY THIRD PARTY LAB
PK sampling X X
Pharmacogenet-ics (PG) sampling
X
Biomarkers X X X
Archived Tissue X
Study flow chart
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Tests
Treatment Period
Cycle 1 Cycle 2
Day 1 (± 3 days) Day 1 (± 3 days)
prior to ganetespib
infusion termination(EOI)*
prior to docetaxel infusion
termination (EOI)*
prior to ganetespib infusion
termination (EOI)*
prior to docetaxel infusion
termination (EOI)*
TESTS TO BE PERFORMED BY THIRD PARTY LAB
PK Sampling: Arm A (Docetaxel only): X X
PK Sampling: Arm B (Ganetespib + Docetaxel): X X X X
Study flow chart – PK sampling
* EOI = End of Infusion
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Material needed: Tests
Scr Treatment Period
Within 4 Weeks of
randomization
Cycle 1 Cycle 2 Cycle 3 Cycle 4 Cycle 5 Cycle _
Day 1 (± 3 days)
Day 15 (±
3 days)
Day 1 (± 3 days)
Day 1 (± 3 days)
Day 1 (± 3 days)
Day 1 (± 3 days)
Day 1 (± 3 days)
SAMPLES TO BE SHIPPED AMBIENT TO BARC
SST tube 8.5 mL (marble/brown stopper)*LDH,
LDH Isoforms 1 1 1 1 1 1 1
Large brown cap cryovial 5 mL LDH 1 1 1 1 1 1 1Clear cap cryovial 5 mL LDH Isoforms 1 1 1 1 1 1 1Red cap cryovial 5 mL (back-up)
LDH/LDH Isoforms 1 1 1 1 1 1 1
Paraffin blocks (histocassette) and/or a minimum of 10 Slides.
Archived Tissue 1
SAMPLES TO BE SHIPPED FROZEN TO BARCSodium Heparin tube 6 mL (green stopper)**
PK sampling 1 or 2 1 or 2
Blue cap cryovial 2 mL (Aliquot A) PK sampling1 or 2x2
1 or 2x2
Red cap cryovial 2 mL (Aliquot B) PK sampling1 or 2x2
1 or 2x2
K2EDTA tube 6 mL(violet stopper)
PG sampling 1Sodium Heparin tube 6 mL (green stopper)**
Biomarkers 1 1 1Orange cap cryovial 2 mL (Aliquot A)-from Sodium Heparin tube 6 mL
Biomarkers 1 1 1Violet cap cryovial 2 mL (Aliquot B)- from Sodium Heparin tube 6 mL
Biomarkers 1 1 1
K2EDTA tube 6 mL (violet stopper)** Biomarkers 1 1 1Green cap cryovial 2 mL (Aliquot A)- from K2EDTA tube 6 mL Biomarkers 1 1 1Clear cap cryovial 2 mL (Aliquot B)- from K2EDTA tube 6 mL Biomarkers 1 1 1
Trial specific material – STUDY DOCUMENTS
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CENTRAL LAB MANUAL
• Use of Requisition Form- label sheet• Description of tests to be carried out• Supplies provided and procedure to re-order supplies through Sample
Material Request Form (SMRF) + semi automatic resupply (order proposal every 6 months)
• Sampling procedures and sample management• Transport of samples to central lab (courier contact)• Analysis and reporting• Lab accreditation certificate & reference ranges
Trial specific material – STUDY DOCUMENTS
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INSTRUCTION LEAFLET• In local language • Summary of procedures with comprehensive pictograms (per visit)
Trial specific material – STUDY DOCUMENTS
REQUISITION FORM
• Collection of subject demographic and visit data• Identification of various samples drawn• ‘Error-proof’: all labels must be used to complete visit• Use one form per subject and per visit day• Apply barcode labels length wise• Every requisition form has a unique requisition # • Send original requisition form along with the samples to BARC.
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To be completed per subject
Labels with unique requisition number should come here (=link between subject and requisition number used)
SHOULD BE KEPT ON SITE!
• Trial specific material – STUDY DOCUMENTS
Log of all samples taken per patient
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SAMPLE LOG FORM
• Trial specific material – STUDY DOCUMENTS
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SAMPLE MATERIAL REQUEST FORM
• Fill out SMRF and fax to BARC @ 516-719-1281 or email to [email protected]
• Re-supply shipping Procedure― Re-supply shipments will be shipped within 5 business
days after receipt of the order.
• Trial specific material – STUDY DOCUMENTS
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EXAMPLE
Trial specific material – SUPPLIES
• Visit specific kits• Local handling
― Pipettes and transfer vials
• Shipment and storage material ― Pre-printed AWB, silver blue box― Ambient white Gel packs (do not freeze or referigerate)― Storage boxes (grid)
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ALL IATA COMPLIANT
EXCLUSIVELY USE BARC SUPPLIES
Trial specific material – SUPPLIES
• INITIAL SUPPLIES
• CONTINUATION SUPPLIES• Use Sampling Material Request
Form or email at:
[email protected] and [email protected]
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Sample Handling - Ambient
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LDH AND LDH ISOFORMS
Immediately after obtaining the blood specimen, invert the tube 8 to 10 times. The SST tube need to site in an upright position for 30 minutes after inversion and before centrifugation.
Sample Handling - Ambient
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TUMOR TISSUE SLIDES
Sample Handling - Frozen
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PHARMACOGENETICS (PG) SAMPLING
Immediately after obtaining the blood specimen, invert the tube 8 to 10 times. No further processing required.
Sample Handling - Frozen
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PK SAMPLING ARM A (DOCETAXEL)
Cycle 1/DAY 1/EOI and Cycle 2/DAY 1/EOI
Immediately after obtaining the blood specimen, invert the tube 8 to 10 times. Centrifuge within 1 hour of sampling.
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Sample Handling - Frozen
PK SAMPLING ARM B (GANETESPIB + DOCETAXEL)
Cycle 1/DAY 1/EOI and Cycle 2/DAY 1/EOI
Immediately after obtaining the blood specimen, invert the tube 8 to 10 times. Centrifuge within 1 hour of sampling.
Sample Handling - Frozen
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BIOMARKER SAMPLING
Immediately after obtaining the blood specimens, invert the tubes 8 to 10 times. Centrifuge within 1 hour of sampling.
Shipping of samples - general
• Subject is best seen in the morning to ensure timely pick-up of the samples
• Call local courier at telephone number provided by BARC within call hours (info sticker present on manual + leaflet)
• Make sure all samples in all boxes are properly labeled and original requisition form is added to box
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Shipping of samples -general
• Courier is prepaid by BARC (BARC account number on Air Waybill)
• Ambient shipments (day of collection)• Monday through Friday
• Frozen shipments (monthly dry ice shipments)• Monday through Wednesday
• Shipments cannot be made on the day before Local Public Holidays or on Local Public Holidays.
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Shipment of Samples – Ambient shipment
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Shipment of Samples – Frozen shipment
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Isothermal transport box
Gel packs stored at –20°C (or below) for at least 72 hours
Cover
Sample holder(s) with ambient samples
Airway bill Date and sign
Requisition form(s)
White storage box with frozen samples
Envelope with bubble foil
Shipment of Samples – Combined shipment
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Data Integrity
• In order to comply with GCP, any omission or inconsistency will be
queried with a Data Clarification Form
• The DCF must be resolved promptly and returned by fax to BARC
I n d u s t r i e p a r k Z w i j n a a r d e 7 , b o x 3 , B - 9 0 5 2 G e n t , B e l g i u m
T e l . + 3 2 9 . 3 2 9 . 2 . 3 2 9 F a x + 3 2 9 . 3 2 9 . 2 . 3 3 0
A P P E N D I X V E X A M P L E D A T A C L A R I F I C A T I O N F O R M
U R G E N T T E L E F A X M E S S A G E f o r D A T A C L A R I F I C A T I O N D a t e 1 9 / 0 6 / 0 0
T o P R O F . D E M O P R O B E K L I N I K B – 1 2 3 4 T R Y O U T
A s o n t h e 1 9 / 0 6 / 0 0 , w e r e c e i v e d a s h i p m e n t f r o m P R O F . D E M O , r e l a t e d t o t h e s t u d y O r g a n o n 3 8 7 0 1 . S o m e d a t a a r e m i s s i n g o r i n c o n s i s t e n t w i t h p r e v i o u s l y o b t a i n e d d a t a . P l e a s e v e r i f y , c o m p l e t e a n d / o r c o n f i r m t h e f o l l o w i n g d a t a t h a t h a v e b e e n f i l e d i n t h e B A R C d a t a b a s e s : L a b R e f N r : 0 0 0 6 - 9 9 9 9 8 M o d i f i c a t i o n s i n t h i s c o l u m n :
P a t i e n t i d e n t i f i c a t i o n o n f i l e S u b j e c t N u m b e r : 9 9 9 9
P a t i e n t I n i t i a l s : X X X D a t e o f B i r t h : G e n d e r : F
C u r r e n t s a m p l e i d e n t i f i c a t i o n
R e q u i s i t i o n N u m b e r : 1 2 3 0 0 6 V i s i t : S C R E E N I N G D a t e o f S a m p l i n g : 1 8 / 0 6 / 0 0 H o u r o f S a m p l i n g : 0 8 : 5 4
- P l e a s e p r o v i d e t h e d a t e o f b i r t h :
V e r i f i e d b y :
T h a n k y o u f o r y o u r c o o p e r a t i o n
N a m e : D a t e : S i g n a t u r e :
P l e a s e s i g n a n d r e t u r n t h e a d a p t e d f o r m b y f a x t o + 3 2 9 . 3 2 9 . 2 . 3 3 0 A c o p y o f t h e a d a p t e d f o r m s h o u l d b e k e p t i n y o u r f i l e s .
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Reporting
• Fax/Email reports with LDH results to site within 24 hrs after reception
• Cumulative reporting (up to two visits)• Missing results are coded: ‘N D’ « Not
done » or ‘N R’ « Not received »
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Reporting
• Out of range values will be flagged with asterix (*) and evaluation box which needs scoring by investigator (CS/NCS)
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