GUIDELINES TUE ENQUIRIES

Transcription

1 Wrld Anti-Dping Prgram GUIDELINES TUE ENQUIRIES BY ACCREDITED LABORATORIES Versin 2.0 June 2018

2 Objective The fllwing guideline is the result f cntinuing effrts t harmnize Labratry reprting prcedures based n the requirements f the Internatinal Standard fr Labratries (ISL) [1], as well as n the bservatins and recmmendatins made by the WADA Labratry Expert Grup (LabEG). This guideline was prduced t assist the Labratries in reprting Presumptive Adverse Analytical Findings (PAAF) exclusively fr the S.3. Beta-2 Agnists and S.9. Gluccrticids drug classes and enquiring with the relevant Testing Authrity (TA) and/r Results Management Authrity (RMA) abut the existence f an apprved Therapeutic Use Exemptin (TUE) befre perfrming cnfirmatin analyses. In accrdance with ISL (prvisin ), the decisin t cnfirm the PAAF r reprt the finding as negative shall be made by the TA and/r r Results Management Authrity (RMA) and it shall be retained by the Labratry as part f the Sample recrd. The frm belw is an example f hw this requirement may be met. It is recmmended that all Labratries refer t this frm when cntacting TAs r RMAs fr the existence f an apprved TUE. 1. Scpe This guideline fllws the rules established in the Wrld Anti-Dping Agency s (WADA) ISL [1] and relevant Technical Dcuments regarding the Analytical Testing f Samples. These requirements are still fully applicable and shall be respected. This Guideline cntains additinal recmmendatins t facilitate the crrespndence between Labratries and TAs and allws fr harmnized recrding f such decisins int ADAMS. Therefre this guideline als prvides guidance n hw t maintain traceability in reprting such decisins until such time that specialized reprting mdules are available in ADAMS. 2. TUE enquiry Requirements The ISL article prvides the ptin fr Labratries t cntact the relevant TA r RMA t enquire if an apprved TUE is n file fr a PAAF fr beta-2-agnists r gluccrticids detected in the Initial Testing Prcedure. In additin, the Labratry shall request guidance as t whether, n the basis f the valid TUE, the TA wishes the Labratry t cnfirm the PAAF r reprt the finding as Negative. It is strngly recmmended that the Labratry utilizes the template frm in the Annex t this guideline (r a Labratry frm cntaining similar descriptive elements) t receive dcumented and signed evidence f the TA s instructins. 3. Reprting Requirements In rder t ensure full traceability f the TA s instructins t cnfirm the PAAF r t reprt the Sample as Negative fr the beta-2 agnist r gluccrticid PAAF, the fllwing guidance shall be fllwed in rder t incrprate the TA s authrizatin int the ADAMS recrd. It is nted that the TUE enquiry frm may be upladed as described belw withut the need fr the TA t un-match the ADAMS recrd. WADA - TUE Enquiries By Accredited Labratries Page 1 f 4

3 The Labratry shall recrd the decisin f the TA int ADAMS. Tw methds are acceptable t update the ADAMS recrd: 1. Attach the TA-apprved TUE Enquiry Frm t ADAMS recrd: Add a statement in the cmments sectin f the ADAMS recrd that clearly identifies that instructins have been received frm the TA based n a TUE enquiry. Fr example, enter the statement in the Analysis Details/Explanatin/Opinin text field: TUE enquiry: refer t attached dcument under activities tab Uplad and attach the signed TUE enquiry instructins (in pdf frmat) thrugh the Activities Tab in the ADAMS recrd (see Appendix 2): Select add activity ; Then brwse under Add Attachment; Select the apprpriate pdf dcument and pen ; Add the statement t subject field TUE Enquiry ; and Click n save. Save the ADAMS recrd and submit. 2. Add a cmment t ADAMS recrd: Add a statement fr the cmments sectin f the ADAMS recrd that clearly describes that the TA cnfirmed the existence f an apprved TUE and that the test result may be recrded as Negative. Enter the statement in the Analysis Details/Explanatin/Opinin text field: TUE Enquiry: The Testing Authrity cnfirmed that a prper TUE is n file fr [substance] and has authrized the reprting f this sample as Negative. TUE Enquiry recrd is n file in the Labratry. WADA - TUE Enquiries By Accredited Labratries Page 2 f 4

4 Labratry Name Labratry Address (r Letterhead) TUE Enquiry Frm TA r RMA: Sample Cde: Sprt/Discipline: Missin Cde/Batch ID/Event : Lab Cde: The Labratry Initial Testing Prcedure applied t the sample abve identified a Presumptive Adverse Analytical Finding that may fall under an apprved Therapeutic Use Exemptin status within the fllwing drug class identified in the WADA Prhibited List: Presumptive Analytical Finding: Drug Class S.3 Beta-2 agnists S.9 Gluccrticids Estimated cncentratin 1 based n initial test: 1 the cncentratin value is a nn-cnfirmed estimatin based n a qualitative initial test result. Name and Title f respnsible persn: Signature: ========================================================= Sectin belw t be cmpleted by the relevant Results Management Authrity: Please indicate belw whether the Labratry is t perfrm a cnfirmatry analysis (based n the existence r absence f a valid TUE fr this substance related t the sample identified abve) D nt cnfirm the Presumptive Adverse Analytical Finding and reprt sample as Negative. (An acceptable TUE, in cmpliance t the TUE Standard, is n file 2 ). Cnfirm the Presumptive Adverse Analytical Finding and reprt cnfirmatin result. 2 It is the rle f the Testing Authrity r Results Management Authrity t ensure that the nature f the substance(s) fund in the sample is/are cmmensurate with the prescriptin as indicated n the granted TUE. Name and title f respnsible persn: Signature f respnsible persn: Organizatin: Please frward this cmpleted frm t the [name] Labratry at Fax: r scientist@labratry.rg WADA - TUE Enquiries By Accredited Labratries Page 3 f 4

5 Appendix: TUE Enquiries by Accredited Labratries Versin 2.0 June 2018 Attaching a TUE enquiry frm t ADAMS recrds via the Activities Tab 1. Nte that the ADAMS recrd will nt need t be unmatched by the TA. 2. The Labratry shall click n the Activities Tab in ADAMS recrd f the relevant Sample cde and then click n the Add Activity buttn. 3. Type the descriptin f the activity in the Subject line (see example belw fr attaching Test Reprts). 4. Under Add Attachment, click n Brwse t retrieve and attach the TA s frwarded TUE enquiry dcument (in pdf frmat) and click n Save. 5. The TUE enquiry will be accessible t the TA and RMA. WADA - TUE Enquiries By Accredited Labratries Page 4 f 4