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SOP Snakes and Ladders
Phongsinghwithaya, Chaninthorn
Created on November 29, 2024
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Transcript
Roll the dice!
Snakes and Ladders SOP
Instructions
SOP
Roll the dice!
Snakes and Ladders SOP
Instructions
SNAKES
Ladders
Ladders
SNAKES
If the player lands on a square where the tail of a snake starts, they go down to a lower square where the headis located.
If the player falls on the bottom of a ladder, they move up to the top square where the ladder ends.
INSTRUCTIONS
Players start with a token - which represents each of them - in the initial square and take turns rolling the die. The tokens move according to the numbering on the board, in ascending order. If, at the end of a move, a player lands on a square where a ladder begins, they move up it to the square where it ends. If, on the other hand, they land on a square where a snake's tail begins, they move down it to the square where its head ends. If a player rolls a 6, they can move twice in a single turn. If a player rolls three consecutive 6's, they must return to the initial square and cannot move their token until they roll a 6 again. The player who reaches the final square is the winner. There is a variation where, if a player is six or fewer squares away from the end, they must roll precisely the number needed to reach it. If the number rolled exceeds the number of remaining squares, the player cannot move.
Will this be QC Failed? Why?
Box 2
When to report protocol deviations in Clinical Vault? A: 7
A - 6 monthsB - 1 yearC - Till drug is marketed
Investigators are required to notify Roche of any changes in financial interest status during the study and for up to_________after site closure.
A - 6 monthsB - 1 yearC - Till drug is marketed
Investigators are required to notify Roche of any changes in financial interest status during the study and for up to_________after site closure.
Who to consult whether an event is a serious breach? A - Principle Investigator B - Study Coordinator C - Line Manager
Serious breaches are to be reported within …..? A - 1 calendar day from date of awareness B - 1 working day from date of awareness C - Depends on line manager D - Same as protocol deviation reporting timeline
CRAs are responsible to review protocol deviation trends and address by implementing CAPAs? True or False?
Site/Subject issues meeting the requirement for GCP Noncompliance and/or Misconduct are to be reported, and the (s)COL is to be informed, within___business day of identification. A - 1 B - 3 C - 5 D - 7
Serious breaches are to be reported within …..? A - 1 calendar day from date of awareness B - 1 working day from date of awareness C - Depends on line manager D - Same as protocol deviation reporting timeline
Will this be QC Failed? Why?
Box 2
When to report protocol deviations in Clinical Vault? A: 7
Who to consult whether an event is a serious breach? A - Principle Investigator B - Study Coordinator C - Line Manager
Will this be QC Failed? Why?
Box 2
When to report protocol deviations in Clinical Vault? A: 7
FDFs for investigators and SC must be present and complete prior to PAV as part of GLG True or False?
Who to consult whether an event is a serious breach? A - Principle Investigator B - Study Coordinator C - Line Manager
IVD is medical tests performed on samples taken from the human body such as blood, urine, or tissue to_______________.A - diagnose diseases B - monitor health conditions C - guide treatment decision. D - All of the above are correct
Who is responsible for reporting AEs related to IVD?
A - Only the manufacturer of the IVDB - The healthcare provider or user of the IVD C - The regulatory authorities D - The regulatory authorities and the healthcare provide
IVD is medical tests performed on samples taken from the human body such as blood, urine, or tissue to_______________.A - diagnose diseases B - monitor health conditions C - guide treatment decision. D - All of the above are correct
What does IVD stand for?A - Intravenous Device B - In Vivo Diagnostics C - In Vitro Diagnostics D - Immunoassay Validation Device
A - 6 monthsB - 1 yearC - Till drug is marketed
Investigators are required to notify Roche of any changes in financial interest status during the study and for up to_________after site closure.
CRAs are responsible to review protocol deviation trends and address by implementing CAPAs? True or False?
What classifies as a serious breach?A: Any event that impacts right, health and wellbeing of study participantsB: Any event that impacts scientific integrity of study C: Any event resulted from PI non-compliance or oversight D: A and B E: All of the above
FDFs for investigators and SC must be present and complete prior to PAV as part of GLG True or False?
Who to consult whether an event is a serious breach? A - Principle Investigator B - Study Coordinator C - Line Manager
How soon must AEs related to IVD be reported to Roche?
A - within 24 hours of awarenessB - within 5 days of awareness C - within 7 days of awareness D - within 30 days of awareness
Site/Subject issues are to be reported within____ calendar days of identification.A: 1 day B: 3 days C: 5 days D: 7 days
Site/Subject issues meeting the requirement for GCP Noncompliance and/or Misconduct are to be reported, and the (s)COL is to be informed, within___business day of identification. A - 1 B - 3 C - 5 D - 7
Serious breaches are to be reported within …..? A - 1 calendar day from date of awareness B - 1 working day from date of awareness C - Depends on line manager D - Same as protocol deviation reporting timeline
What action does CRA have to take when FDF cannot be obtained in three attempts?A - Complete Global: Note to File for Unable to Obtain Financial Disclosure Form (FOR-0304717) B - Escalate to Country Clinical Operations C - Raise an issue on Clinical Vault D - All of the above
Who is responsible for reporting AEs related to IVD?
A - Only the manufacturer of the IVDB - The healthcare provider or user of the IVD C - The regulatory authorities D - The regulatory authorities and the healthcare provide
What classifies as a serious breach?A: Any event that impacts right, health and wellbeing of study participantsB: Any event that impacts scientific integrity of study C: Any event resulted from PI non-compliance or oversight D: A and B E: All of the above
Who to consult whether an event is a serious breach? A - Principle Investigator B - Study Coordinator C - Line Manager
What action does CRA have to take when FDF cannot be obtained in three attempts?A - Complete Global: Note to File for Unable to Obtain Financial Disclosure Form (FOR-0304717) B - Escalate to Country Clinical Operations C - Raise an issue on Clinical Vault D - All of the above
Who to consult whether an event is a serious breach? A - Principle Investigator B - Study Coordinator C - Line Manager
A - 6 monthsB - 1 yearC - Till drug is marketed
Investigators are required to notify Roche of any changes in financial interest status during the study and for up to_________after site closure.
A - 6 monthsB - 1 yearC - Till drug is marketed
Investigators are required to notify Roche of any changes in financial interest status during the study and for up to_________after site closure.
Who is responsible for reporting AEs related to IVD?
A - Only the manufacturer of the IVDB - The healthcare provider or user of the IVD C - The regulatory authorities D - The regulatory authorities and the healthcare provide
What action does CRA have to take when FDF cannot be obtained in three attempts?A - Complete Global: Note to File for Unable to Obtain Financial Disclosure Form (FOR-0304717) B - Escalate to Country Clinical Operations C - Raise an issue on Clinical Vault D - All of the above
Site/Subject issues are to be reported within____ calendar days of identification.A: 1 day B: 3 days C: 5 days D: 7 days
FDFs for investigators and SC must be present and complete prior to PAV as part of GLG True or False?
Will this be QC Failed? Why?
Box 2
When to report protocol deviations in Clinical Vault? A: 7
What classifies as a serious breach?A: Any event that impacts right, health and wellbeing of study participantsB: Any event that impacts scientific integrity of study C: Any event resulted from PI non-compliance or oversight D: A and B E: All of the above
FDFs for investigators and SC must be present and complete prior to PAV as part of GLG True or False?
What action does CRA have to take when FDF cannot be obtained in three attempts?A - Complete Global: Note to File for Unable to Obtain Financial Disclosure Form (FOR-0304717) B - Escalate to Country Clinical Operations C - Raise an issue on Clinical Vault D - All of the above
What classifies as a serious breach?A: Any event that impacts right, health and wellbeing of study participantsB: Any event that impacts scientific integrity of study C: Any event resulted from PI non-compliance or oversight D: A and B E: All of the above
What does IVD stand for?A - Intravenous Device B - In Vivo Diagnostics C - In Vitro Diagnostics D - Immunoassay Validation Device
Who is responsible for reporting AEs related to IVD?
A - Only the manufacturer of the IVDB - The healthcare provider or user of the IVD C - The regulatory authorities D - The regulatory authorities and the healthcare provide
What does IVD stand for?A - Intravenous Device B - In Vivo Diagnostics C - In Vitro Diagnostics D - Immunoassay Validation Device
IVD is medical tests performed on samples taken from the human body such as blood, urine, or tissue to_______________.A - diagnose diseases B - monitor health conditions C - guide treatment decision. D - All of the above are correct
How soon must AEs related to IVD be reported to Roche?
A - within 24 hours of awarenessB - within 5 days of awareness C - within 7 days of awareness D - within 30 days of awareness
How soon must AEs related to IVD be reported to Roche?
A - within 24 hours of awarenessB - within 5 days of awareness C - within 7 days of awareness D - within 30 days of awareness
What classifies as a serious breach?A: Any event that impacts right, health and wellbeing of study participantsB: Any event that impacts scientific integrity of study C: Any event resulted from PI non-compliance or oversight D: A and B E: All of the above
How soon must AEs related to IVD be reported to Roche?
A - within 24 hours of awarenessB - within 5 days of awareness C - within 7 days of awareness D - within 30 days of awareness
IVD is medical tests performed on samples taken from the human body such as blood, urine, or tissue to_______________.A - diagnose diseases B - monitor health conditions C - guide treatment decision. D - All of the above are correct
Site/Subject issues meeting the requirement for GCP Noncompliance and/or Misconduct are to be reported, and the (s)COL is to be informed, within___business day of identification. A - 1 B - 3 C - 5 D - 7
Site/Subject issues are to be reported within____ calendar days of identification.A: 1 day B: 3 days C: 5 days D: 7 days
Serious breaches are to be reported within …..? A - 1 calendar day from date of awareness B - 1 working day from date of awareness C - Depends on line manager D - Same as protocol deviation reporting timeline
SNAKES
Ladders
Ladders
SNAKES
If the player lands on a square where the tail of a snake starts, they go down to a lower square where the headis located.
If the player falls on the bottom of a ladder, they move up to the top square where the ladder ends.
INSTRUCTIONS
Players start with a token - which represents each of them - in the initial square and take turns rolling the die. The tokens move according to the numbering on the board, in ascending order. If, at the end of a move, a player lands on a square where a ladder begins, they move up it to the square where it ends. If, on the other hand, they land on a square where a snake's tail begins, they move down it to the square where its head ends. If a player rolls a 6, they can move twice in a single turn. If a player rolls three consecutive 6's, they must return to the initial square and cannot move their token until they roll a 6 again. The player who reaches the final square is the winner. There is a variation where, if a player is six or fewer squares away from the end, they must roll precisely the number needed to reach it. If the number rolled exceeds the number of remaining squares, the player cannot move.
What does IVD stand for?A - Intravenous Device B - In Vivo Diagnostics C - In Vitro Diagnostics D - Immunoassay Validation Device
Site/Subject issues are to be reported within____ calendar days of identification.A: 1 day B: 3 days C: 5 days D: 7 days
Site/Subject issues meeting the requirement for GCP Noncompliance and/or Misconduct are to be reported, and the (s)COL is to be informed, within___business day of identification. A - 1 B - 3 C - 5 D - 7
Will this be QC Failed? Why?
Box 2
When to report protocol deviations in Clinical Vault? A: 7