Balance Sheets in Clinical Trials and accounting made easy

A balance sheet records Assets (Things that have future economic value), Liabilities (Amount Owed) and Equity (Ownership).

There  are a few definitions we need to get out of the way:

Asset is a resource controlled by the entity as a result of past events and from which future economic benefits are expected to flow to the entity (IASB Framework).

Liabilities are defined as a present obligation of the entity arising from past events, the settlement of which is expected to result in an outflow of the entity's resources.

Equity is defined as “any contract that evidences a residual interest in the assets of an entity after deducting all of its liabilities.

Remember to check back when using these terms.

So Equity = Asset less liabilities
OR Assets = Equity + Liabilities

BALANCE SHEET OF XXX AS AT A PARTICULAR DATE
Assets
There are fixed assets 

• Buildings
• Houses (less loss of value of asset / depreciation). (Increase in valuation of assets.)
• Motor Vehicles
• Equipment and machinary
• Long term investments

There are current assets 

• Cash
• Accounts receivable from debtors

Equity

• All the assets less all the liabilities
• Profit from the operations (as recorded in the income statement)
• Losses on the value of assets

Liabilities

• Long term debt
• Cash
• Accounts payable to debtors 

1. A dangerous good is:

•  A. Any article or substance capable of posing a risk to health, safety, property, or the environment
•  B. Listed in or classified by the IATA regulations
•  C. Also known as hazardous material or hazmat
•  D. All of the above
•  E. A and C
•  A dangerous good is:
  You selected: D. All of the above
  Correct! Dangerous goods are defined as any article or substance capable of posing a risk to health, safety, property, or the environment that are also listed in or classified by the IATA regulations. Dangerous goods are also known as hazardous material or hazmat.

  ---

  2. When shipping specimens, laboratories must follow general regulations regarding:
  You selected: C. Classification, Packaging, Labeling, Documentation, and Training
  Correct! Laboratories must follow general regulations regarding Classification, Packaging, Labeling, Documentation, and Training.
  3. Infectious substances are included in:
  You selected: D. Hazard Class 6, Division 6.2
  Correct! Infectious substances are included in Hazard Class 6, Division 6.2.

  ---

  4. Infectious substances are categorized as one of the following:
  You selected: B. Category A, Infectious Substance Affecting Humans/Category B, Biological Substance
  Correct! Infectious substances are categorized as either Category A, Infectious Substance Affecting Humans or Category B, Biological Substance.

  ---

  5. Cultures are categorized as Category A when they are:
  You selected: A. Intended for the intentional generation of pathogens
  Incorrect. Any culture intended for the intentional generation of pathogens as well as any culture shipped for identification purposes must be shipped as Category A, Infectious Substance Affecting Humans.

  PART II: DANGEROUS GOODS - Proper Packaging of Specimens

  6. When shipping by air, Packing Instruction 650 is always used when shipping:
  You selected: A. Specimens categorized as Category B
  Correct! When shipping by air, Packing Instruction 650 is used when packing substances categorized as Category B, Biological Substance.

  ---

  7. Mayo Medical Laboratories provides the following certified containers:
  You selected: B. T347 double 10-pound Styro berry box
  Incorrect. Mayo Medical Laboratories provides two certified containers: the T347 double 10-pound Styro berry box and the T570 small white container.

  ---

  8. When packing Category A specimens, the following is FALSE:
  You selected: C. The package must be shipped in a box with a smallest external dimension no less than 10 inches
  Correct! This is not one of the requirements when packing Category A, Infectious Substance Affecting Humans. Among others, Packing Instruction 602 requires that your package must: be packed in leak-proof primary and secondary packaging, display the name and telephone number of a responsible contact person on the exterior, be shipped in a box with a smallest external dimension no less than 100 mm (4 inches), include an itemized list of contents between the secondary packaging and outer packaging, and withstand 95kPa of pressure.

  ---

  9. When packing any Biological Substance Category B, the following is always true:
  You selected: B. Does not require a UN certified box
  Correct! Packing instruction 650 states that you need a rigid sturdy box for Category B Biological Substance. A UN certified box is only required for Category A Infectious Substance.

  PART II: DANGEROUS GOODS - Proper Labeling of Specimens

  10. Packages containing Category A substances must be labeled with:
  You selected: E. All of the above
  Correct! Among other requirements, packages containing substances classified as Category A, Infectious Substance Affecting Humans must be labeled with: the name and address of the shipper and consignee, the 6.2 Infectious Substance label, the UN2814 marking, and the proper shipping name, "Infectious Substance Affecting Humans."

  ---

  11. A cargo-only aircraft label must be used for:
  You selected: B. Category A shipments over 50 milliliters or 50 grams
  Correct! A cargo-only aircraft label is required when shipping over 50 milliliters or 50 grams of any substance classified as Category A, Infectious Substance Affecting Humans.

  ---

  12. When shipping dry ice by air:
  You selected: A. The net weight of the dry ice, in kilograms, must be marked on the outside of the package
  Correct! When shipping dry ice by air, the net weight of the dry ice, in kilograms, must be marked on the outside of the package.

  Part II: DANGEROUS GOODS - Transportation & Proper Documentation of Category A Specimens

  13. When using proper shipping names and technical names on Category A shipments, the following is TRUE:
  You selected: C. The technical name must accompany the proper shipping name when indicated in the IATA or DOT regulations
  Incorrect. This answer is incomplete. You will use the proper shipping name and, in some cases, the technical name, when sending Category A shipments. The proper shipping name is a standard name used to identify an article or substance during transport. To ship legally and safely, you must always use the proper shipping name on the outside of the package in addition to the Shipper's Declaration Form. The technical name is a recognized chemical name-currently used in scientific and technical handbooks, texts, journals-which must accompany the proper shipping name when indicated in the IATA or DOT regulations.

  ---

  14. A Shipper's Declaration for Dangerous Goods:
  You selected: E. B and C
  Correct! A Shipper's Declaration for Dangerous Goods is required when shipping any Category A, Infectious Substance Affecting Humans. Among other requirements, the Shipper's Declaration for Dangerous Goods must be retained for two years.
  15. Recurrent training on shipping dangerous goods is required:
  You selected: A. Every two years for air, every three years for ground
  Correct! Employee training must occur every two years for laboratories who ship by air. If shipping only by ground, employee training is required every three years.
  
  
  
  
  
  
  

1. A dangerous good is:

•  A. Any article or substance capable of posing a risk to health, safety, property, or the environment
•  B. Listed in or classified by the IATA regulations
•  C. Also known as hazardous material or hazmat
•  D. All of the above
•  E. A and C
•  A dangerous good is:
  You selected: D. All of the above
  Correct! Dangerous goods are defined as any article or substance capable of posing a risk to health, safety, property, or the environment that are also listed in or classified by the IATA regulations. Dangerous goods are also known as hazardous material or hazmat.

  ---

  2. When shipping specimens, laboratories must follow general regulations regarding:
  You selected: C. Classification, Packaging, Labeling, Documentation, and Training
  Correct! Laboratories must follow general regulations regarding Classification, Packaging, Labeling, Documentation, and Training.
  3. Infectious substances are included in:
  You selected: D. Hazard Class 6, Division 6.2
  Correct! Infectious substances are included in Hazard Class 6, Division 6.2.

  ---

  4. Infectious substances are categorized as one of the following:
  You selected: B. Category A, Infectious Substance Affecting Humans/Category B, Biological Substance
  Correct! Infectious substances are categorized as either Category A, Infectious Substance Affecting Humans or Category B, Biological Substance.

  ---

  5. Cultures are categorized as Category A when they are:
  You selected: A. Intended for the intentional generation of pathogens
  Incorrect. Any culture intended for the intentional generation of pathogens as well as any culture shipped for identification purposes must be shipped as Category A, Infectious Substance Affecting Humans.

  PART II: DANGEROUS GOODS - Proper Packaging of Specimens

  6. When shipping by air, Packing Instruction 650 is always used when shipping:
  You selected: A. Specimens categorized as Category B
  Correct! When shipping by air, Packing Instruction 650 is used when packing substances categorized as Category B, Biological Substance.

  ---

  7. Mayo Medical Laboratories provides the following certified containers:
  You selected: B. T347 double 10-pound Styro berry box
  Incorrect. Mayo Medical Laboratories provides two certified containers: the T347 double 10-pound Styro berry box and the T570 small white container.

  ---

  8. When packing Category A specimens, the following is FALSE:
  You selected: C. The package must be shipped in a box with a smallest external dimension no less than 10 inches
  Correct! This is not one of the requirements when packing Category A, Infectious Substance Affecting Humans. Among others, Packing Instruction 602 requires that your package must: be packed in leak-proof primary and secondary packaging, display the name and telephone number of a responsible contact person on the exterior, be shipped in a box with a smallest external dimension no less than 100 mm (4 inches), include an itemized list of contents between the secondary packaging and outer packaging, and withstand 95kPa of pressure.

  ---

  9. When packing any Biological Substance Category B, the following is always true:
  You selected: B. Does not require a UN certified box
  Correct! Packing instruction 650 states that you need a rigid sturdy box for Category B Biological Substance. A UN certified box is only required for Category A Infectious Substance.

  PART II: DANGEROUS GOODS - Proper Labeling of Specimens

  10. Packages containing Category A substances must be labeled with:
  You selected: E. All of the above
  Correct! Among other requirements, packages containing substances classified as Category A, Infectious Substance Affecting Humans must be labeled with: the name and address of the shipper and consignee, the 6.2 Infectious Substance label, the UN2814 marking, and the proper shipping name, "Infectious Substance Affecting Humans."

  ---

  11. A cargo-only aircraft label must be used for:
  You selected: B. Category A shipments over 50 milliliters or 50 grams
  Correct! A cargo-only aircraft label is required when shipping over 50 milliliters or 50 grams of any substance classified as Category A, Infectious Substance Affecting Humans.

  ---

  12. When shipping dry ice by air:
  You selected: A. The net weight of the dry ice, in kilograms, must be marked on the outside of the package
  Correct! When shipping dry ice by air, the net weight of the dry ice, in kilograms, must be marked on the outside of the package.

  Part II: DANGEROUS GOODS - Transportation & Proper Documentation of Category A Specimens

  13. When using proper shipping names and technical names on Category A shipments, the following is TRUE:
  You selected: C. The technical name must accompany the proper shipping name when indicated in the IATA or DOT regulations
  Incorrect. This answer is incomplete. You will use the proper shipping name and, in some cases, the technical name, when sending Category A shipments. The proper shipping name is a standard name used to identify an article or substance during transport. To ship legally and safely, you must always use the proper shipping name on the outside of the package in addition to the Shipper's Declaration Form. The technical name is a recognized chemical name-currently used in scientific and technical handbooks, texts, journals-which must accompany the proper shipping name when indicated in the IATA or DOT regulations.

  ---

  14. A Shipper's Declaration for Dangerous Goods:
  You selected: E. B and C
  Correct! A Shipper's Declaration for Dangerous Goods is required when shipping any Category A, Infectious Substance Affecting Humans. Among other requirements, the Shipper's Declaration for Dangerous Goods must be retained for two years.
  15. Recurrent training on shipping dangerous goods is required:
  You selected: A. Every two years for air, every three years for ground
  Correct! Employee training must occur every two years for laboratories who ship by air. If shipping only by ground, employee training is required every three years.
  
  
  
  
  
  
  

HAM-A Scale

Hamilton Rating Scale for Anxiety
Gold Standard - measure for Anxiety - /56
Severity - 0 to 4 - total score for 14 items is 56
Assesses psychic and somatic anxiety

MINI Scale

MINI International Neuropsychiatric Interview (MINI)

1. Validated, structured interview
2. Assesses the major Axis I disorders in DSM-IV and ICD-10
3. Assesses current and some lifetime diagnoses

Modules

1. Major Depressive Episodes
2. Suicidality
3. Manic Episode
4. Panic Disorder
5. Agoraphobia
6. Social Phobia & Social Anxiety Disorder
7. Obsessive Compulsive Disorder
8. Posttraumatic Stress Disorder
9. Alcohol Dependance and Abuse
10. Substance Dependence and Abuse (non Alcohol)
11. Psychotic Disorders
12. Anorexia Nervosa
13. Bulimia Nervosa
14. Generalized Anxiety Disorder
15. Medical, Organic, Drug Cause Ruled out
16. Antisocial Personality Disorder

Healthcare Resource Utilisation and Work Absence - HRUWA

Clinician administrable
- to capture information about the costs of illness

1. Healthcare utlilization
2. Loss or work productivity

Define contact - telephone call, appointment or visit with someone

1. Hospital admission
2. Emergency Room 
3. General Practitioner
4. Consultant / Specalist

Diagnostic procedures

1. Physical examination
2. X-ray/CT
3. Neurophysiology tests
4. Laboratory tests

Missed work

1. Subject
2. Spouse and family member or friend

Discontinuation Emergent Signs and Symptoms (DESS)

43 Items
The DESS is a 43 item checklist of symptoms associated with discontinuation of antidepressant agents. It is administered during the Post Treatment phase and should be completed by the subject.