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[9] Cook J D et al. |
The Characterization of Human Urine for Specimen Validity Determination in Workplace Drug Testing: A Review. |
J Anal Toxicol 24 : 579- 588, 2000 [Comment: Current versions of WADA Technical Documents may be found at https://www.wada -ama.org/en/what -we-do/science- medical/laboratories ] ABP Operating Guidelines – Version 9.0 – July 2023 Page 58/91 3.7. |
Results Management Requirements and Procedures for the Athlete Biological Passport (ISRM Annex C) C.1 Administrative Management C.1.1 The requirements and procedures described in this Annex apply to all modules of the Athlete Biological Passport except where expressly stated or implied by the context. |
C.1.2 These processes shall be administered and managed by an Athlete Passport Management Unit on behalf of the Passport Custodian. |
The Athlete Passport Management Unit will initially review profiles to facilitate targeting recommendations for the Passport Custodian when appropriate or refer to the Experts as required. |
Management and communication of the biological data, Athlete Passport Management Unit reporting and Expert reviews shall be recorded in ADAMS and be shared by the Passport Custodian with other Anti -Doping Organizations with Testing Authority over the Athlete to coordinate further Passport Testing as appropriate. |
A key element for Athlete Biological Passport management and communication is the Athlete Passport Management Unit Report in ADAMS, which provides an overview of the current status of the Athlete’s Passport including the latest targeting recommendations and a summary of the Expert reviews. |
C.1.3 This Annex describes a step- by-step approach to the review of an Athlete’s Passport : a) The review begins with the application of the Adaptive Model . |
b) In case of an Atypical Passport Finding or when the Athlete Passport Management Unit considers that a review is otherwise justified, an Expert conducts an initial review and returns an evaluation based on the information available at that time. |
c) In case of a “Likely doping” initial review, the Passport is then subjected to a review by three (3) Experts including the Expert who conducted the initial review. |
d) In case of a “Likely doping” consensus of the three (3) Experts , the process continues with the creation of an Athlete Biological Passport Documentation Package. |
e) An Adverse Passport Finding is reported by the Athlete Passport Management Unit to the Passport Custodian if the Experts’ opinion is maintained after review of all information available at that stage, including the Athlete Biological Passport Documentation Package . |
f) The Athlete is notified of the Adverse Passport Finding and offered the opportunity to provide explanations. |
g) If after review of the explanations provided by the Athlete, the Experts maintain their unanimous conclusion that it is highly likely that the Athlete Used a Prohibited Substanc e or a Prohibited Method, an anti -doping rule violation is asserted against the Athlete by the Passport Custodian. |
ABP Operating Guidelines – Version 9.0 – July 2023 Page 59/91 C.2 Initial Review Phase C.2.1 Review by the Adaptive Model The requirements and procedures described in this Annex apply to all modules of the Athlete Biological Passport except where expressly stated or implied by the context. |
C.2.1.1. |
In ADAMS, the Adaptive Model automatically processes data on the biological Markers of the Athlete Biological Passport . |
These Markers include primary Markers that are defined as the most specific to doping and secondary Markers that provide supporting evidence of doping in isolation or in combination with other Markers . |
The Adaptive Model predicts for an individual an expected range within which a series of Marker values falls assuming a normal physiological condition. |
Outliers correspond to those values outside of the 99% -range, from a lower limit corresponding to the 0.5th percentile to an upper limit corresponding to the 99.5th percentile (1:100 chance or less that this result is due to normal physiological variation). |
A specificity of 99% is used to identify Atypical Passport Findings . |
In the case of sequence deviations ( sequence Atypical Passport Findings ), the applied specificity is 99.9% (1:1000 chance or less that this is due to normal physiological variation). |
C.2.1.2. |
An Atypical Passport Finding is a result generated by the Adaptive Model in ADAMS which identifies either : a) a primary Marker(s) value(s) as being outside the Athlete’s intra-individual range, or, b) a longitudinal profile consisting of (up to) the last five (5) valid primary Marker values as deviating from expected ranges (sequence Atypical Passport Findings ), assuming a normal physiological condition. |
An Atypical Passport Finding requires further attention and review. |
C.2.1.3. |
Primary and Secondary Markers C.2.1.3.1 For the Haematological Module, the Adaptive Model automatically processes in ADAMS two primary Markers , haemoglobin concentration (HGB) and stimulation index OFF- score (OFFS), and two secondary Markers, the reticulocyte percentage (RET%) and the Abnormal Blood Profile Score (ABPS) . |
HGB and RET% are Marke rs measured in blood ABP Samples while OFFS and ABPS are calculated using values of Markers measured in blood ABP Samples . |
C.2.1.3.2 The Steroidal Module comprises steroid Markers measured in urine and/or blood (serum) Samples . |
For urine Samples , the Adapt ive Model automatically processes in ADAMS one primary Marker , the Testosterone to Epitestosterone ratio (T/E), and four (4) secondary Markers : the Androsterone to Testosterone ratio (A/T), the Androsterone to Etiocholanolone ratio (A/Etio), the 5α-Androstane-3α,17β-diol to 5β-Androstane- 3α,17β-diol ratio ( 5αAdiol/5βAdiol) ABP Operating Guidelines – Version 9.0 – July 2023 Page 60/91 and the 5α-Androstane- 3α,17β-diol to Epitestosterone ratio (5αAdiol/E). |
For blood Samples , the Adaptive Model automatically processes in ADAMS one primary Marker, the Testosterone to Androstenedione ratio (T/A4). |
C.2.1.3.3 For the Endocrine Module, the Adaptive Model automatically processes in ADAMS one primary Marker , the GH -2000 score calculated using a formula including two (2) secondary Markers , insulin -like growth factor -I (IGF -I) and N -terminal pro- peptide of type III collagen (P -III-NP) measured in blood (serum) Samples . |
C.2.1.4. |
Departure from WADA Athlete Biological Passport requirements C.2.1.4.1 If there is a departure from WADA Athlete Biological Passport requirements for Sample collection, transport and analysis, the biological Marker result obtained from this Sample affected by the non-conformity shall not be considered in the Adaptive Model calculations (for example, RET% can be affected but not HGB under certain transportation conditions). |
C.2.1.4.2 A Marker result which is not affected by the non- conformity can still be considered in the Adaptive Model calculations. |
In such case, the Athlete Passport Management Unit shall provide the specific explanations supporting the inclusion of the result (s). |
In all cases, the Sample shall remain recorded in the Athlete’s Passport . |
The Experts may include all results in their review provided that their conclusions may be validly supported when taking into account the effects of the non-conformity. |
C.2.2 The Initial Expert Review C.2.2. |
1 A Passport generating an Atypical Passport Finding, or for which a review is otherwise justified, shall be sent by the Athlete Passport Management Unit to an Expert for review in ADAMS. |
This should take place within seven (7) days following the generation of the Atypical Passport Finding in ADAMS. |
The review of the Passport shall be conducted based on the Passport and other basic information (e.g. |
Competition schedules), which may be available, such that the Expert is blinded to the identity of the Athlete . |
The Expert shall provide the individual report in ADAMS and this should take place within seven (7) days after receipt of the request. |
C.2.2.2 If a Passport has been recently reviewed by an Expert and the Passport Custodian is in the process of executing a specific multi -Sample Testing strategy on the Athlete , the Athlete Passport Management Unit may delay the review of a Passport generating an Atypical Passport Finding triggered by one of the Samples collected in this context until completion of the planned series of tests. |
In such situations, the Athlete Passport Management Unit shall clearly indicate the reason for delaying the review of the Passport in the Athlete Passport Management Unit Report . |
ABP Operating Guidelines – Version 9.0 – July 2023 Page 61/91 C.2.2.3 If the first and unique result in a Passport is flagged as an Atypical Passport Finding by the Adaptive Model , the Athlete Passport Management Unit may recommend the collection of an additional Sample before initiating the initial Expert review. |
C.2.2.4 Review in the absence of an Atypical Passport Finding C.2.2.4.1 A Passport may also be sent for Expert review in the absence of an Atypical Passport Finding where the Passport includes other elements otherwise justifying a review. |
These elements may include, without limitation: a) Data not considered in the Adaptive Model ; b) Any abnormal levels and/or variations of Marker(s) ; c) Signs of hemodilution in the haematological Passport ; d) Marker levels below the corresponding Limit of Quantification of the assay; or e) Intelligence in relation to the Athlete concerned. |
C.2.2.4.2 An Expert review initiated in the above -mentioned situations may result in the same Consequences as an Expert review triggered by an Atypical Passport Finding. |
C.2.2.5 Expert Evaluation C.2.2.5.1 When evaluating a Passport , an Expert weighs the likelihood that the Passport is the result of the Use of a Prohibited Substance or Prohibited Method against the likelihood that the Passport is the result of a normal physiological or pathological condition in order to provide one of the following opinions: “Normal”, “Suspicious”, “Likely doping” or “Likely medical condition”. |
For a “Likely doping” opinion, the Expert shall come to the conclusion that the likelihood that the Passport is the result of the Use of a Prohibited Substance or Prohibited Method outweighs the likel ihood that the Passport is the result of a normal physiological or pathological condition. |
[Comment to Article C.2.2.5.1: When evaluating competing propositions, the likelihood of each proposition is evaluated by the Expert based on the evidence available for that proposition. |
It is acknowledged that it is the relative likelihoods (i.e., likelihood ratio) of the competing propositions that ultimately determine the Expert ’s opinion. |
For example, where the Expert is of the view that a Passport is highly likely the result of the Use of a Prohibited Substance or Prohibited Method, it is necessary for a “Likely doping” evaluation that the Expert consider that it is unlikely that it may be the result of a ABP Operating Guidelines – Version 9.0 – July 2023 Page 62/91 normal physiological or pathological condition. |
Similarly, where the Expert is of the view that a Passport is likely the result of the Use of a Prohibited Substance or Prohibited Method, it is necessary for a “Likely doping” evaluation that the Expert consider that it is highly unlikely that it may be the result of a normal physiological or pathological condition.] |
C.2.2.5.2 To reach a conclusion of “Likely doping” in the absence of an Atypical Passport Finding, the Expert shall come to the opinion that it is highly likely that the Passport is the result of the Use of a Prohibited Substance or Prohibited Method and that it is highly unlikely that the Passport is the result of a normal physiological or pathological condition. |
C.2.3 Consequences of t he Initial Review Depending on the outcome of the initial review, the Athlete Passport Management Unit will take the following action: Expert Evaluation Athlete Passport Management Unit Action “Normal” Continue normal Testing plan. |
“Suspicious” Provide recommendations to the Passport Custodian for Target Testing, Sample analysis and/or requesting further information as required. |
“Likely doping” Send to a panel of three (3) Experts , including the initial Expert , as per section C.2 of this Annex C. “Likely medical condition” If recommended by the Expert , inform the Athlete as soon as possible via the Passport Custodian (or send to other Experts ). |
[Comment to Article C.2.3: The Athlete Biological Passport is a tool to detect the possible Use of Prohibited Substance(s) or Prohibited Method(s) and it is not intended as a health check or for medical monitoring. |
It is important that the Passport Custodi an educate the Athletes to ensure that they undergo regular health monitoring and not rely on the Athlete Biological Passport for this purpose. |
Nevertheless, the Passport Custodian should inform the Athlete in case the Passport indicates a likely pathology as determined by the Experts .] |
ABP Operating Guidelines – Version 9.0 – July 2023 Page 63/91 C.3 Review by Three (3) Experts C.3.1 In the event that the opinion of the appointed Expert in the initial review, pending other explanation to be provided at a later stage, is that of “Likely doping”, the Passport shall then be sent by the Athlete Passport Management Unit to two (2) additional Experts for review. |
This should take place within seven (7) days after the reporting of the initial review. |
These additional reviews shall be conducted without knowledge of the initial review. |
These three (3) Experts now constitute the Expert Panel , composed of the Expert appointed in the initial review and these two (2) other Experts . |
C.3.2 The review by the three (3) Experts must follow the same procedure, where applicable, as presented in section C.2.2 of this Annex. |
The three (3) Experts shall each provide their individual reports in ADAMS. |
This should take place within seven (7) days after receipt of the request. |
C.3.3 The Athlete Passport Management Unit is responsible for liaising with the Experts and for advising the Passport Custodian of the subsequent Expert assessment. |
The Experts can request further information, as they deem relevant for their review, notably information related to medical conditions, Competition schedule and/or Sample(s) analysis results. |
Such requests are directed via the Athlete Passport Management Unit to the Passport Custodian. |
C.3.4 A unanimous opinion among the three (3) Experts is necessary in order to proceed further towards declaring an Adverse Passport Finding, which means that all three (3) Experts render an opinion of “Likely doping”. |
The conclusion of the Experts must be reached with the three (3) Experts assessing the Athlete’s Passport with the same data. |
[Comment to Article C.3.4: The three (3) Expert opinions cannot be accumulated over time based on different data.] |
C.3.5 To reach a conclusion of “Likely doping” in the absence of an Atypical Passport Finding , the Expert Panel shall come to the unanimous opinion that it is highly likely that the Passport is the result of the Use of a Prohibited Substance or Method and that there is no reasonably conceivable hypothesis under which the Passport is the result of a normal physiological condition and highly unlikel y that it is the result of pathological condition. |
C.3.6 In the case when two (2) Experts evaluate the Passport as “Likely doping” and the third Expert as “Suspicious”, the Athlete Passport Management Unit shall promptly confer with the Expert Panel before they finalize their opinion. |
The group can also seek advice from an appropriate outside Expert , although this must be done while maintaining strict confidentiality of the Athlete’s Personal Information. |
C.3.7 If no unanimity can be reached among the three (3) Experts , the Athlete Passport Management Unit shall promptly report the Passport as “Suspicious”, update the Athlete Passport Management Unit Report , and recommend that the Passport Custodian pursue additional Testing and/or gather intelligence on the Athlete (refer to Information Gathering and Intelligence Sharing Guidelines), as appropriate. |
ABP Operating Guidelines – Version 9.0 – July 2023 Page 64/91 C.4 Conference Call, Compilation of the Athlete Biological Passport Documentation Package and Joi nt Expert Report C.4.1 If a unanimous opinion of “Likely doping” is rendered by all three (3) Experts , the Athlete Passport Management Unit shall promptly declare a “ Unanimous l ikely doping” evaluation in the Athlete Passport Management Unit Report in ADAMS and should organize a conference call with the Expert Panel to initiate the next steps for the case, including proceeding with the compilation of the Athlete Biological Passport Documentation Package (see Technical Document for Athlete Passport Management Units ) and drafting of the joint Expert report. |
In preparation for this conference call, the Athlete Passport Management Unit should coordinate with the Passport Custodian to compile any potentially relevant inform ation to share with the Experts (e.g. |
suspicious analytical findings, relevant intelligence and relevant pathophysiological information). |
C.4.2 Once completed, the Athlete Biological Passport Documentation Package shall be sent by the Athlete Passport Management Unit to the Expert Panel , who will review it and provide a joint Expert report to be signed by all three (3) Experts . |
The conclusion within the joint Expert report shall be reached without interference from the Passport Custodian . |
If necessary, the Expert Panel may request complementary information from the Athlete Passport Management Unit . |
C.4.3 At this stage, the identity of the Athlete is not mentioned but it is accepted that specific information provided may allow to identify the Athlete. |
This shall not affect the validity of the process. |
C.4.4 If after review of the Athlete Biological Passport Documentation Package, the Expert Panel is no longer unanimous in their opinion of “ Likely doping”, the Expert Panel shall update their respective opinions in ADAMS and the Athlete Passport Management Unit shall update the Athlete Passport Management Unit Report accordingly. |
C.5 Issuing an Adverse Passport Finding C.5.1 If the Expert Panel confirms their unanimous position of “ Likely doping”, the Athlete Passport Management Unit shall promptly declare an Adverse Passport Finding in ADAMS that includes a written statement of the Adverse Passport Finding, the Athlete Biological Passport Documentation Package and the joint Expert report . |
C.5.2 After reviewing the Athlete Biological Passport Documentation Package and joint Expert report, the Passport Custodian shall: a) Notify the Athlete of the Adverse Passport Finding in accordance with Article 5.3.2; b) Provide the Athlete the Athlete Biological Passport Documentation Package and the joint Expert report; c) Invite the Athlete to provide their own explanation, in a timely manner, of the data provided to the Passport Custodian. |
C.6 Review of Explanation from Athlete and Disciplinary Proceedings C.6.1 Upon receipt of any explanation and supporting information from the Athlete, which should be received within the specified deadline, the Athlete Passport Management Unit shall forward it to the Expert Panel for review with any additional information that the Expert Panel considers necessary to render its opinion in coordination with both the ABP Operating Guidelines – Version 9.0 – July 2023 Page 65/91 Passport Custodian and the Athlete Passport Management Unit , and update their recommendation in ADAMS as “Athlete’s explanation provided to Expert panel” . |
At this stage, the review is no longer anonymous. |
The Expert Panel shall promptly reassess or reassert the case and reach one of the following conclusions: a) Unanimous opinion of “Likely doping” by the Experts based on the information in the Passport and any explanation provided by the Athlete; or b) Based on the available information, the Experts are unable to reach a unanimous opinion of “Likely doping” set forth above. |
[Comment to Article C.6.1: Such a reassessment shall also take place when the Athlete does not provide any explanation.] |
C.6.2 If the Expert Panel expresses the opinion set forth in section C.6.1(a), then the Athlete Passport Management Unit shall promptly update their recommendation in ADAMS as “APF confirmed” and inform the Passport Custodian, who shall charge the Athlete in accordance with Article 7 above and continue with Results Management in accordance with this International Standard. |
C.6.3 If the Expert Panel expresses the opinion set forth in section C.6.1(b), the Expert Panel shall promptly update their respective opinions in ADAMS and the Athlete Passport Management Unit shall update the Athlete Passport Management Unit Report , accordingly, and recommend the Passport Custodian to pursue additional Testing and/or gather intelligence on the Athlete (refer to Information Gathering and Intelligence Sharing Guidelines), as appropriate. |
The Passport Custodian shall notify the Athlete and WADA of the outcome of the review. |
C.7 Passport Re-setting C.7.1 In the event the Athlete has been found to have committed an anti -doping rule violation based on the Passport , the Athlete’s Passport shall be reset by the Passport Custodian at the start of the relevant period of Ineligibility and a new Biological Passport ID shall be assigned in ADAMS. |
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