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POLICY AND PROCEDURE MANUAL
Pennington Biomedical
POLICY NO. 377.00 ORIGIN DATE: 07/2014
IMPACTS: ALL PERSONNEL LAST REVISED: 1/31/2018
SUBJECT: CORE USAGE EFFECTIVE: 5/4/2018
SOURCE: AED FOR CORES AND RESOURCES VERSION NO. 2
PURPOSE
To establish guidelines for core usage and define all on-site procedures and/or tests that are to be performed by core personnel.
POLICY
Guidelines for Core Usage
Any projects funded by corporate sponsors that are conducted exclusively at Pennington Biomedical are required to use the core laboratories for the procedures listed in this policy and will not be allowed to subcontract to outside facilities, provided that the services can be performed here.
All federally funded projects (or those funded by associations such as ADA, AHA, TOS, etc.) that are conducted exclusively at Pennington Biomedical are required to use the core laboratories for the procedures listed in the policy unless a savings of ≥ 20% can be achieved by subcontracting with another facility, or the subcontracting lab is needed for scientific expertise that cannot be provided here.
Any pilot projects from federally funded centers are required to use the core laboratories for the procedures listed in the policy. However, the costs for the clinical core services will be cost shared by the institution at a rate of 50% if the total budget exceeds the funding limit of the pilot grant. If the budget is less than the funding limit, the core rates will not be cost shared. Multi-site or collaborative projects that involve expertise from other sites may be considered as exceptions to the above with the approval of the executive director.
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Guidelines for Testing Procedures
Procedures for each of the 13 cores at Pennington Biomedical are classified into two categories:
1. Procedures/tests performed by core personnel
2. Procedures/tests that may be performed by trained non-core personnel
Procedures for each of the 13 units are listed in the appendices attached to this policy.
Appendix A – Comparative Biology
Appendix B – Transgenics
Appendix C – Genomics
Appendix D – Cell Biology and BioImaging
Appendix E – Imaging
Appendix F – Clinical Trials Unit (Inpatient, Outpatient, Intervention, Pharmacy)
Appendix G – Mass Spectrometry
Appendix H – Clinical Chemistry
Appendix I – Data Management
Appendix J – Metabolic Kitchen
Appendix K – Exercise Testing
Appendix L – Dietary Assessment
Appendix M – Recruiting
OVERSIGHT
The Associate Executive Director for Cores and Resources and/or his or her designee will oversee this policy. Any exceptions to the policy will be approved by the Executive Director.
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Appendix A – Comparative Biology
All procedures/tests are performed by core personnel.
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Appendix B – Transgenics
All procedures/tests are performed by core personnel.
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Appendix C – Genomics
Procedures/tests performed by core personnel:
1. Next generation sequencing a. Illumina NextSeq
b. Illumina Miseq
2. Sanger sequencing a. AB 3130 capillary sequencer
3. Illumina microarray 4. Robotics pipetting station 5. Genomics Core server & software
Procedures/tests that may be performed by core personnel or trained non-core personnel:
1. Next generation sequencing library preparation
2. Nucleic acid quality control
a. Agilent Bioanalyzer
b. Qbit fluorometer
c. Nanodrop spectrophotometer
d. QiaCube
3. RT qPCR
a. AB 7900
b. MJR thermocycler
c. BioRad ddPCR
4. Sonication
a. Covaris S
b. BioRuptor
5. Cellular bioenergetics
a. Seahorse 24XF
6. Computer workstation
a. Primer design
b. qPCR data analysis
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Appendix D – Cell Biology and BioImaging
Procedures/tests performed by core personnel:
1. Tissue processing
a. Sakura VIP6 tissue processor
2. Autostaining
a. Leica ST5020 multistainer
b. Leica BOND IHC stainer
3. Coverslipping
a. Leica CV5030 coverslipper
4. High-speed cell sorting
a. Sony Biotechnology (formally iCyt) Reflection
5. Slide scanning
a. Hamamatsu NanoZoomer
6. Cassette/slide printing
a. Leica Cassette/slide printer
Procedures/tests that may be performed by core personnel or trained non-core personnel:
1. Tissue embedding
a. Thermo HistoCentre 3
2. Tissue sectioning
a. Leica CM1950 cryostats
b. Microm HM550 and HM560 cryostats
c. Leica RM2255 rotary microtomes
d. Microm HM355 rotary microtome
e. Leica SM2000 sliding microtome
3. Flow cytometry
a. BD FACSCalibur
4. Imaging
a. Zeiss 510 Meta confocal
b. Leica TCS SP5 confocal
c. Leica DM6000/TIRF system
d. Zeiss Axioskop 40
e. Zeiss Axiovert 40
f. Everest imaging system
g. Perkin Elmer spinning disk system
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5. Laser microdissection
a. Leica LMD6000
6. Plate reading
a. Molecular Devices FlexStation
7. Computer workstations
a. Dell workstation
b. Mac pro workstation
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Appendix E – Imaging
Procedures/tests performed by core personnel:
1. Dual-energy X-ray absorptiometry (DXA) - acquisition and analysis
2. Ultrasound - acquisition
3. X-ray - acquisition
4. Peripheral arterial tone (PAT) - acquisition
Procedures/tests that may be performed by trained non-core personnel:
1. BodPod - acquisition
2. Quickscan - acquisition
3. Ambulatory blood pressure monitor (ABPM) –acquisition
4. Magnetic resonance imaging (MRI) – acquisition and analysis
5. Magnetic resonance spectroscopy (MRS) – acquisition and analysis
6. Ultrasound – analysis
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Appendix F – Clinical Trials Unit (Inpatient, Outpatient, Intervention, Pharmacy)
Procedures/tests performed by inpatient core personnel:
1. 24-hour stay
2. Autoclaving
3. Biopsy-Fat
4. Biopsy-Fat & Muscle
5. Biopsy-Muscle
6. Chamber 12 hr
7. Chamber 24 hr
8. Clamp for 1 step
9. Clamp Driver 1 step
10. Clamp-tracers
11. Clamp Additional RN per hour
12. Clamp additional driver per hour
13. Clamp additional draws per hour
14. Cleaning fee per hr
15. Core Temperature
16. DLW Dosing
17. Injections
18. Inpatient staff per hr charge
19. IV blood draw and supplies
20. IV Insertion
21. IV procedure-Day LPN per hr
22. IV procedure- Evening LPN per hr
23. IV procedure- Night LPN per hr
24. LNP day per hr
25. LPN evening per hr
26. LPN night per hr
27. LPN weekend per hr
28. Medication dosing
29. MEI Chamber 24 hr
30. Misc supplies
31. NP per hour
32. Overnight stay
33. RMR Delta Trac- per 30 min
34. RMR Delta Trac- per 30 min increments additional
35. RMR Max II- per 30 min
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36. RMR Max II- per 30 min increments additional
37. RN per hour
38. Sable Chamber Cost per hour
39. Scientific consultant-Oversight Chamber
40. Scientific consultant-Oversight RMR
41. Study Startup fee per hour
42. Venipuncture
43. Continuous Glucose Monitor Insertion
44. Biopsy Processing Set-up
45. Lumbar Puncture
46. Clamp for 2 step
47. IV Medication Administration
Procedures/tests performed by outpatient core personnel:
1. Additional Binder - Studies > 1 yr
2. Additional Chart - Studies > 1yr
3. Advanced Vital Signs
4. Adverse Events
5. Assent - Minor
6. Binder Fee
7. Biopsy
8. BP Monitor (Application/Removal)
9. Chart Fee
10. Clamp supplies (no isotope)
11. Clinic Measures
12. Clinic Supply/Room
13. Compounding Active Drug Capsules
14. Compounding Individual Capsules
15. Compounding Placebo Capsules
16. Concomitant Medications
17. Concomitant Medications -FU
18. Consent (Amendment)
19. Consent (initial)
20. Consent (Initial)- Level 2
21. Coordinator Fee Inpt Visit
22. Coordinator Fee per Study Visit
23. Coordinator Fee Screening Visit
24. CRF Data Entry per visit (Internal)
25. Data Collection/Review/Instruction
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26. Dietitian Consultation
27. Dietitian Instruction
28. Dispensing
29. Drug Receipt/Accountability
30. ECHO interpretation
31. EKG/Vo2 interpretation
32. Front Desk Reception
33. FSIGTT
34. Medical Oversight- per visit
35. Medical Oversight Level 2- per visit
36. Medical Records EOS Visit
37. Medical Records Screening/Rand
38. Medical Records Study Visits
39. Medical Records Non-Clinic Staff Visits
40. Medication Dispense/Compliance
41. Medication Injection/Instruction
42. Misc Consultation
43. Miscellaneous
44. IRB Continuing Review Study in Analysis-per hour
45. Nonsterile Compounding
46. OGTT
47. Packaging and Labeling Drug
48. Pharmacist Fee Per Hour
49. Pharmacy EOS Closeout
50. Pharmacy Study Setup
51. Regulatory Preparation
52. SAE Collection/Reporting
53. Sterile Compounding/Clamp/HR
54. Study Coordinator Study Set Up Level 1
55. Study Coordinator Study Set Up Level 2
56. Study Set up
57. Water
Procedures/tests performed by interventional core personnel:
1. Intervention Session Level 1 per hour
2. Intervention Session Level 2 per hour
3. Intervention Session Level 3 per hour
4. Group Intervention Level 1 per participant
5. Group Intervention Level 2 per participant
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6. Questionnaires Level 1
7. Questionnaires Level 2
8. Intervention Study Set Up Level 1
9. Intervention Study Set Up Level 2
10. Intervention Study Set Up Level 3
11. Group Orientation Level 1 per participant
12. Group Orientation Level 1 with Consent/Assent per participant
13. Group Orientation Level 2 per participant
14. Group Orientation Level 2 with Consent/Assent per participant
15. Orientation Individual
16. Orientation Individual with Consent
17. Randomization
18. Data Entry per visit
19. Data Monitoring per hour
20. Research Specialist Fee Level 1
21. Research Specialist Fee Level 2
22. Research Specialist Fee Level 3
23. Project Coordination/Administration per hour
24. Off-Campus Travel per hour
25. Run-In per hour
26. Specialist Meeting per hour
27. Miscellaneous
Procedures/tests performed by all Clinical Trials Unit core personnel:
1. Vital signs 2. Height/Weight 3. Questionnaires
Procedures/tests performed by all inpatient and outpatient core personnel:
1. Finger sticks 2. Physical Exams 3. EKG 4. Medical History/Physical 5. Medication Dispense/Compliance
Procedures/tests performed by all outpatient and interventional core personnel:
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1. Telephone visits 2. Device Application/Removal
Procedures performed by outpatient, exercise, or inpatient core personnel:
1. EKG 2. BP Monitor (application/removal)
Procedures/tests that are not endpoint measures and may be performed by core personnel or trained non-core personnel:
1. Adverse events during study 2. Vital signs during study 3. Height/weight during study 4. Concomitant medications during study 5. Questionnaires
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Appendix G – Mass Spectrometry
Procedures/tests performed by core personnel:
1. DLW (8 samples includes D2 and O18)
2. TBW (D2 only - 2 samples)
3. TBW (O18 only - 2 samples)
4. D2 tissue
5. D2 serum
6. C13 - breath
7. Fatty Acid profile (serum)
8. Fatty Acid/Glycerol (DNL - tissue)
9. Fatty Acid/Glycerol (DNL - serum)
10. Amino Acid - muscle
11. Amino Acid - serum
12. Glucose/glycerol
13. Biopsy processing
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Appendix H – Clinical Chemistry
Procedures/tests performed by core personnel:
1. 1 plex cytokine
2. 1,25 Vit D
3. 13 plex cytokine
4. 2 plex cytokine
5. 25 plex cytokine
6. 25 Vit D
7. 29 plex cytokine
8. 3 plex cytokine
9. 4 plex cytokine
10. 42 plex cytokine
11. 5 plex cytokine
12. 6 plex cytokine
14. 7 plex cytokine
15. ACE
16. ACTH
17. Adiponectin
18. Adiponectin, hmw
19. Albumin
20. Alk Phos
21. Alpha carotene
22. ALT
23. amino acids
24. Amylase
25. Androstenedione
26. Angiotensin I
27. Angiotensin II
28. ANP
29. Apo A
30. Apo B
31. Apo C III
32. AST
33. BAP
34. BDNF
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35. Beta carotene
36. BHBA
37. Blood collection/processing
38. Urine collection/processing
39. PT/INR (OLOL)
40. aPTT (OLOL)
41. RPR (OLOL)
42. HepC (OLOL)
43. HIV (OLOL)
44. HbsAG (OLOL)
45. Calcitonin (OLOL)
46. bromide
47. BUN
48. C peptide
49. caffeine
50. Calcium
51. CARBONYLS
52. catecholamines
53. CBC
54. cck
55. chem 15
56. chem 26
57. Chloride
58. Cholesterol
59. Cholesterol-cholestech
60. CK
61. CO2
62. Cortisol
63. Cortisol, saliva
64. Cotinine
65. Creatinine
66. CRF
67. Crosslaps
68. CRP
69. DHEA, saliva
70. DHEAs
71. Direct Bilirubin
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72. endothelin 1
73. Endotoxin
74. Erythropoeitin
75. Estradiol
76. Estradiol, saliva
77. Estrone Sulfate
78. Ethanol
79. ETOH, microdialysis
80. Ethanol Breath Test
81. Ferritin
82. FFA (hs)
83. FGF-1
84. fgf-23
85. Folate
86. Free Testosterone
87. Fructosamine
88. FSH
89. fT3
90. fT4
91. GGT
92. Ghrelin
93. Ghrelin, active
94. GIP
95. glp-1
96. Glucagon
97. Glucose
98. Glucose, Microdialysis
99. GLUTATHIONE PEROXIDASE
100. Glycerol
101. Growth hormone
102. HbA1C
103. HCG
104. HDL
105. Hepcidin
106. Homocysteine
107. IGF-1
108. IGFBP1
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109. IGFBP3
110. IgG
111. IgA
112. IgM
113. Insulin
114. Insulin mouse ELISA
115. Iron
116. ISOPROSTANES
117. Lactate
118. LBP
119. LDH
120. Leptin
121. LH
127. Lipase
128. Lipids
129. LpA
130. LPS
131. Magnesium
132. Melatonin
133. Microalbumin (semi quant)
134. Microalbumin (quant)
135. Myoglobin
136. npy
137. Occult blood
138. Osteocalcin
140. Ox 40 Ligand
141. oxyntomodulin
142. PAI-1
143. Pancreatic polypeptide
144. Phosphorus
145. PINP
146. Potassium
147. Prealbumin
148. Progesterone
149. Progesterone, saliva
150. Proinsulin
151. Prolactin
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152. PSA
153. PT
154. PTH
155. pyy
156. RBP4
157. Renin
158. Resistin
159. Reverse T3
160. SCD40 Ligand
161. Serum Amyloid A
162. SHBG
163. Sodium
164. sTRF
165. SUPEROXIDE DISMUTASE
166. T uptake
167. T3
168. T4
169. TAS
170. TBG
171. Testosterone, 2000
172. Testosterone, saliva
173. Thyroglobulin
174. TIBC
175. TNF receptor II
176. Total Bilirubin
177. Total Protein
178. Transferrin
179. TRAP
180. Triglyceride
181. Troponin
182. TSH
183. UPDG
184. Uric Acid
185. Urinalysis
186. Urine drug screen
187. urine nitrogen
188. vasopressin
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189. Vitamin A
190. Vitamin B12
191. VITAMIN C
192. VITAMIN E
193. Urine chromium
194. Urine lactulose
195. Urine mannitol
196. Urine sucralose
197. Urine sucrose
198. white blood cells
Procedures/tests that may be performed by core personnel or trained non-core personnel:
1. Whole blood glucose (finger stick)
2. HbA1c (finger stick)
3. Cholesterol, HDL, LDL, triglycerides (finger stick)
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Appendix I – Data Management
The preferred method of data capture into the central clinical database is via file upload. Most instruments are capable of producing output data files that can be processed using customized software to allow for data upload to the database. Programmers in Computing Services, Research Computing Group create and maintain this custom software. Database security rights prohibit development outside of the core.
Procedures/tests performed by core personnel:
1. All pre-study setup tasks including but not limited to:
a. Assigning a Pennington clinic study number and name in the clinic database
b. Creating web screener (with non-study specific and/or study specific questions)
c. Setting up the study for Clinic Data Access availability
d. Data security administration
e. Creating study-specific data entry case report forms
f. Creating study-specific double data entry screens
2. Process approved HIPAA privacy board query requests for recruiting purposes
3. Create and maintain all applications that interface directly with the clinic database
4. Create email alerts for study personnel based on scheduled appointments
5. Security on all applications that interface with the clinic database, as well as off-the-
shelf software that includes Protected Health Information (PHI)
6. Provide study-specific reports from clinic data
7. Database corrections
8. Post-study data locking
9. Data transfer to outside sponsors or collaborators
10. REDCap Administration for Pennington projects
Procedures/tests that may be performed by core personnel or trained non-core personnel:
1. Perform manual double data entry using applications provided by the data
management group (RCG). All established data management policies and
procedures followed by the trained RCG data entry clerks must be followed by non-
core personnel. Non-core personnel who will perform manual data entry must
provide proof of completion of high-level HIPAA security training and certification of
training by RCG. *NOTE: Data entry performed outside of the core will incur data
management costs to cover data quality control audits, corrections, and application
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maintenance. The preferred method is to use the data entry services provided by the
core.
2. REDCap Project Development. Projects developed outside the core will still require
oversight by REDCap Admin and may incur charges for administrative tasks.
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Appendix J – Metabolic Kitchen
Procedures/tests performed by core personnel:
1. Weekday/to-go standard breakfast
2. Weekday/to-go specialized breakfast
3. Weekday/to-go standard lunch
4. Weekday specialized lunch
5. Weekday/to-go standard supper
6. Weekday/to-go specialized supper
7. Weekday/to-go standard all meals
8. Weekday specialized all meals
9. Snack
10. Weekend standard breakfast
11. Weekend specialized breakfast
12. Weekend standard lunch
13. Weekend specialized lunch
14. Weekend standard supper
15. Weekend specialized supper
16. Weekend standard all meals
17. Weekend specialized all meals
18. Chamber 12hr (supper only)
19. Weekend chamber 12hr (supper only)
20. Chamber all-meals
21. Weekend chamber all-meals
22. Chamber specialized
23. Weekend chamber specialized
24. Clamp Meal
25. Buffet
26. SCC
27. Food intake lunch
28. Food intake dinner
29. Food intake single item
30. Weekend food intake single item
31. Beverage prep
32. Smoothie
33. Quiche/specialized item
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34. Specialized baked item
35. Standard sandwich
36. Homogenizing
37. Preparing food for validation
38. Kitchen RD menu planning
39. Data request
40. Demo kitchen supper (includes ordering and food storage)
41. Food distribution
42. Food ordering
43. Kitchen RD counseling
44. Food storage (per rack per month)
45. Snack/beverage cart setup
46. Destruction fee (per case)
47. Nonweighted snack
Procedures/tests that may be performed by core personnel or trained non-core personnel:
1. VAS before and after meal
2. Weekend VAS before and after meal
3. Weigh back
4. Meal monitoring
5. Weekend meal monitoring
6. Food intake weigh back (multi-item)
7. Weekend food intake weigh back (multi-item)
8. Food intake weigh back (single-item)
9. Weekend food intake weigh back (single-item)
10. Participant weight
11. Taste test (clinic)
12. Product accountability/distribution
13. Randomization assignment
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Appendix K – Exercise Testing
Procedures/tests performed by core personnel:
1. VO2max Test (Bike and Treadmill)
2. Steady-State Testing (Bike and Treadmill)
3. Muscular Performance Testing (Biodex)
4. 1-RM Test
5. Handgrip
6. GAITRite
7. Step Test
8. Free-Living Activities/Activities of Daily Living
9. Short Physical Performance Battery (SPPB)
10. Metered Walk Test
11. Stair Climb
12. Skinfolds
13. Sit-and-Reach Test
14. Lactic Acid Assessment
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Appendix L – Dietary Assessment
Procedures/tests performed by core personnel:
1. Group and individual dietary counseling 2. FFQ 3. Diet history questionnaires 4. Food recall, 24 hour
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Appendix M – Recruiting
Procedures/tests performed by core personnel:
Phone screen
Procedures/tests that may be performed by core personnel or trained non-core personnel:
Web screen
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