Biomedical IMPACTS: ALL PERSONNEL LAST REVISED: … - Core Usage Policy.pdf · POLI Y AN PRO UR MANUAL Pennington Biomedical POLICY NO. 377.00 ORIGIN DATE: 07/2014 IMPACTS: ALL PERSONNEL

1 | P a g e P o l i c y 3 7 7 . 0 0 C o r e U s a g e

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.


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.


Appendix A – Comparative Biology

All procedures/tests are performed by core personnel.


Appendix B – Transgenics

All procedures/tests are performed by core personnel.


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


Appendix D – Cell Biology and BioImaging


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


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


5. Laser microdissection

a. Leica LMD6000

6. Plate reading

a. Molecular Devices FlexStation

7. Computer workstations

a. Dell workstation

b. Mac pro workstation


Appendix E – Imaging


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


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


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


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



4. Group Intervention Level 1 per participant

5. Group Intervention Level 2 per participant


6. Questionnaires Level 1

7. Questionnaires Level 2

8. Intervention Study Set Up Level 1



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



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:


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


Appendix G – Mass Spectrometry


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


Appendix H – Clinical Chemistry


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


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


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


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


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


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


1. Whole blood glucose (finger stick)

2. HbA1c (finger stick)

3. Cholesterol, HDL, LDL, triglycerides (finger stick)


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.


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


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


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.


Appendix J – Metabolic Kitchen


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


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


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


Appendix K – Exercise Testing


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


Appendix L – Dietary Assessment


1. Group and individual dietary counseling 2. FFQ 3. Diet history questionnaires 4. Food recall, 24 hour


Appendix M – Recruiting


Phone screen


Web screen

Documents

Biomedical IMPACTS: ALL PERSONNEL LAST REVISED: … - Core Usage Policy.pdf · POLI Y AN PRO UR MANUAL Pennington Biomedical POLICY NO. 377.00 ORIGIN DATE: 07/2014 IMPACTS: ALL PERSONNEL